Clinical Algorithm for Post-Stroke Gait Training With C-Brace

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02892760

Enrollment

Registered

2016-09-08

Start date

2017-02-13

Completion date

2019-01-08

Last updated

2021-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemiparesis Due to Stroke, Hemiplegia Due to Stroke

Brief summary

The purpose of this study is to develop a clinical algorithmic-based evaluation and treatment approach for C-Brace for use by persons with hemiparesis or hemiplegia due to stroke.

Interventions

DEVICEC-Brace

C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Age 18 - 65 years * Diagnosis of hemiparesis or hemiplegia following stroke * Presence of abnormal walking pattern * Poor knee control during stance phase * Cognitive ability to (or care provider) manage daily charging of battery * Cognitive ability to follow commands * Hip flexor muscle strength grade 3 or greater or the ability to perform reciprocal gait using compensatory patterns

Exclusion criteria

* Weight \> 275 lbs. (Includes body weight and weight of heaviest object carried) * Less than 2° of ankle motion * Severe spasticity of the quadriceps (MAS \>3) and/or uncontrolled spasticity of the quadriceps * Severe spasticity of other lower limb muscles (MAS \>3) * Fixed genuvalgum exceeding 10° beyond anatomic neutral valgum * Any fixed genuvarum exceeding anatomic neutral varum. * Hip or knee flexion contractures greater than 10° * Presence of chronic obstructive pulmonary disease (COPD) * Chronic heart failure - New York Heart Association (NYHA) stages 3 and 4

Design outcomes

Primary

Measure	Time frame	Description
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis	week 5	During the 10 Meter Walk Test (10MWT), infrared light emitting diode markers will be attached to bilateral lower extremities. The marker data will be recorded using the Northern Digital Inc (NDI) Optotrak Certus motion capture system. Marker data will be processed using custom Matlab program to determine lower extremity joint excursion. Joint excursion is the range of motion of a particular joint, and the range of motion is reported in degrees. After stroke, one side of the body is affected, and joint excursion for various joint angles (of hip, knee, and ankle) are reported for both sides of the body (affected side of body and unaffected side of body).
Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)	week 5	Bipolar surface electrodes will be placed on the bilateral major leg muscles to record electromyography (1000Hz, Motion Labs 16-Channel EMG System). The EMG amplitude (in volts) will be calculated over the whole gait cycle during the 10 Meter Walk Test (10MWT), in which the participant walks 10 meters. After stroke, one side of the body is affected, and data for various muscles are reported for both sides of the body (affected side of body and unaffected side of body).
Metabolic Expenditure During Walking	week 5	Change in metabolic expenditure during walking will be indicated by energy expenditure. Energy Expenditure will be measured by the K4 b2 Cosmed as follows: Oxygen cost will be calculated from oxygen consumption as the product of gait speed and body weight. Oxygen consumption will be collected on a breath-by-breath basis measured by a portable metabolic system (K4 b2 Cosmed). Prior to the testing, the system will be calibrated using room air and reference gas mixture. During the testing, the subject will wear a face mask and a heart rate monitor at all times and will be asked to breathe normally.

Secondary

Measure	Time frame	Description
Change in Hip Extensors Strength as Assessed by Dynamometry	week 0, week 9	Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as hip extensors.
Change in Hip Abductors Strength as Assessed by Dynamometry	week 0, week 9	Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as hip abductors.
Change in Hip Adductors Strength as Assessed by Dynamometry	week 0, week 9	Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as hip adductors.
Change in Knee Flexors Strength as Assessed by Dynamometry	week 0, week 9	Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as knee flexors.
Change in Knee Extensors Strength as Assessed by Dynamometry	week 0, week 9	Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as knee extensors.
Change in Ankle Dorsiflexors Strength as Assessed by Dynamometry	week 0, week 9	Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as ankle dorsiflexors.
Change in Ankle Plantarflexors. Strength as Assessed by Dynamometry	week 0, week 9	Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as ankle plantarflexors.
Score on the Timed Up and Go Test	week 0	Assesses mobility, balance, walking ability, and fall risk in older adults. The test measures the time it takes the subject to perform a sit to stand from a chair with arms, walk to a mark on the ground 10 feet away and return to the seated position in the chair with arms. This test has been used in assessing stroke recovery with high reliability and validity.
Number of Participants With Knee Joint Range of Motion Within Normal Limits as Assessed by Goniometry	week 0	Range of motion will be measured on knee joints using goniometry (goniometry is the use of a device called a goniometer to measure range of motion of a joint in degrees). After stroke, one side of the body is affected. For each participant, the range of motion of their affected knee will be measured and also the range of motion of their other knee (the unaffected knee) will be measured \[it is possible that a participant will have a range of motion within normal limits for both knees (affected knee and unaffected knee)\].
Number of Participants With Ankle Joint Range of Motion Within Normal Limits as Assessed by Goniometry	week 0	Range of motion will be measured on ankle joints using goniometry (goniometry is the use of a device called a goniometer to measure range of motion of a joint in degrees). After stroke, one side of the body is affected. For each participant, the range of motion of their affected ankle will be measured and also the range of motion of their other ankle (the unaffected ankle) will be measured \[it is possible that a participant will have a range of motion within normal limits for both ankles (affected ankle and unaffected ankle)\].
Motor Impairment as Determined by the Fugl-Meyer Assessment	week 0	The Fugl-Meyer Assessment evaluates and measures recovery of movement in individual post stroke. The Fugl-Meyer has been used in both clinical and research settings and is one of the most widely used quantitative measures of motor impairment. It uses an ordinal scale for scoring of 17 items for the lower limb component and 7 items on the balance component, for a total of 24 items. Each of the 24 items is scored as 0 (cannot perform), 1 (can perform partially), or 2 (can perform fully), with a total score ranging from 0 to 48, with a higher score indicating less impairment.
Spasticity as Assessed by the Modified Ashworth Scale (MAS)	week 0	This test measures spasticity in patients with lesions of the Central Nervous System by testing resistance to passive movement about a joint with varying degrees of velocity. Scores range from 0-4, with 0 indicating normal muscle tone and 4 indicating very high spasticity. The investigators will measure spasticity in lower limbs.
Static Balance as Assessed by the Berg Balance Scale (BBS)	week 0	A 14-item objective measure designed to assess static balance and fall risk in adult populations, with a total score range of 0 to 56 (higher scores represent better functional outcome). This test has been widely used to measure functional recovery in stroke patients with high reliability.
Gait Speed as Assessed by the 10 Meter Walk Test (10MWT)	week 0	Measure of gait speed. Subjects will walk a total of 14 meters at their preferred walking speed and at a fast pace. The test measures the time it takes the subject to complete the middle 10 meters of the walk.
Aerobic Capacity as Assessed by Peak VO₂ Per Kilogram Body Weight During the Six-minute Walk Test (6MWT)	week 0	The participant will perform the 6MWT, in which the participant will walk as far as possible in six minutes. During the 6MWT, the peak volume of oxygen consumed per minute (peak VO₂) will be measured by a portable metabolic system. Data are reported as peak volume of oxygen (in milliliters) consumed per kilogram bodyweight per minute per meter walked \[milliliters/kilogram/minute/meter (mL/kg/min/m)\].
Number of Participants With Bilateral Hip Range of Motion Within Normal Limits as Assessed by Goniometry	week 0	Range of motion will be measured on bilateral hip using goniometry (goniometry is the use of a device called a goniometer to measure range of motion of a joint in degrees). After stroke, one side of the body is affected. For each participant, the range of motion of their affected hip will be measured and also the range of motion of their other hip (the unaffected hip) will be measured \[it is possible that a participant will have a range of motion within normal limits on both hip sides (affected hip and unaffected hip)\].
Mental State as Assessed by the Folstein Mini Mental State Examination (MMSE)	week 0	Mini Mental State Examination provides information about orientation, attention, learning, calculation, delayed recall, and construction. Several studies report acceptable validity of MMSE as a screening instrument and its relationship to functional outcome in stroke population. Total score ranges from 0 to 30, with a higher score indicating a better outcome.
Change in Hip Flexors Strength as Assessed by Dynamometry	week 0, week 9	Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as hip flexors.

Countries

United States

Participant flow

Participants by arm

Arm	Count
With C-brace C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking. C-Brace: C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.	15
Total	15

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Withdrawal by Subject	3

Baseline characteristics

Characteristic	With C-brace
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	3 Participants
Age, Categorical Between 18 and 65 years	12 Participants
Age, Continuous	58.5 years STANDARD_DEVIATION 8.5
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	2 Participants
Race (NIH/OMB) Black or African American	6 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	7 Participants
Region of Enrollment United States	15 Participants
Sex: Female, Male Female	5 Participants
Sex: Female, Male Male	10 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 15
other Total, other adverse events	8 / 15
serious Total, serious adverse events	1 / 15

Outcome results

Primary

Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)

Bipolar surface electrodes will be placed on the bilateral major leg muscles to record electromyography (1000Hz, Motion Labs 16-Channel EMG System). The EMG amplitude (in volts) will be calculated over the whole gait cycle during the 10 Meter Walk Test (10MWT), in which the participant walks 10 meters. After stroke, one side of the body is affected, and data for various muscles are reported for both sides of the body (affected side of body and unaffected side of body).

Time frame: week 5

Arm	Measure	Group	Value (MEAN)	Dispersion
With C-brace	Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)	Affected Medial gastrocnemius	0.2183 volts	Standard Deviation 0.1011
With C-brace	Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)	Unaffected Tibialis anterior	0.2791 volts	Standard Deviation 0.0595
With C-brace	Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)	Unaffected Soleus	0.3095 volts	Standard Deviation 0.0574
With C-brace	Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)	Affected Tibialis anterior	0.2627 volts	Standard Deviation 0.0914
With C-brace	Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)	Affected Soleus	0.2484 volts	Standard Deviation 0.0641
With C-brace	Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)	Affected Vastus medialis	0.2211 volts	Standard Deviation 0.0837
With C-brace	Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)	Affected Rectus femoris	0.2513 volts	Standard Deviation 0.0607
With C-brace	Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)	Affected Biceps femoris	0.3136 volts	Standard Deviation 0.0723
With C-brace	Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)	Affected Semimembranous	0.2184 volts	Standard Deviation 0.0734
With C-brace	Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)	Unaffected Medial gastrocnemius	0.2322 volts	Standard Deviation 0.0898
With C-brace	Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)	Unaffected Vastus medialis	0.2508 volts	Standard Deviation 0.0827
With C-brace	Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)	Unaffected Rectus femoris	0.2827 volts	Standard Deviation 0.0873
With C-brace	Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)	Unaffected Biceps femoris	0.2654 volts	Standard Deviation 0.0912
With C-brace	Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)	Unaffected Semimembranous	0.2835 volts	Standard Deviation 0.0895

Primary

Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)

Time frame: week 9

Arm	Measure	Group	Value (MEAN)	Dispersion
With C-brace	Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)	Affected Tibialis anterior	0.2639 volts	Standard Deviation 0.0897
With C-brace	Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)	Affected Soleus	0.2776 volts	Standard Deviation 0.0755
With C-brace	Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)	Affected Medial gastrocnemius	0.3312 volts	Standard Deviation 0.095
With C-brace	Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)	Affected Vastus medialis	0.2149 volts	Standard Deviation 0.1062
With C-brace	Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)	Affected Rectus femoris	0.2146 volts	Standard Deviation 0.1072
With C-brace	Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)	Affected Biceps femoris	0.2795 volts	Standard Deviation 0.0905
With C-brace	Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)	Affected Semimembranous	0.2781 volts	Standard Deviation 0.1045
With C-brace	Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)	Unaffected Tibialis anterior	0.3152 volts	Standard Deviation 0.0689
With C-brace	Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)	Unaffected Soleus	0.3057 volts	Standard Deviation 0.0649
With C-brace	Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)	Unaffected Medial gastrocnemius	0.2598 volts	Standard Deviation 0.0767
With C-brace	Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)	Unaffected Vastus medialis	0.2770 volts	Standard Deviation 0.0812
With C-brace	Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)	Unaffected Rectus femoris	0.2754 volts	Standard Deviation 0.088
With C-brace	Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)	Unaffected Biceps femoris	0.3026 volts	Standard Deviation 0.1161
With C-brace	Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)	Unaffected Semimembranous	0.2877 volts	Standard Deviation 0.1002

Primary

Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis

During the 10 Meter Walk Test (10MWT), infrared light emitting diode markers will be attached to bilateral lower extremities. The marker data will be recorded using the Northern Digital Inc (NDI) Optotrak Certus motion capture system. Marker data will be processed using custom Matlab program to determine lower extremity joint excursion. Joint excursion is the range of motion of a particular joint, and the range of motion is reported in degrees. After stroke, one side of the body is affected, and joint excursion for various joint angles (of hip, knee, and ankle) are reported for both sides of the body (affected side of body and unaffected side of body).

Time frame: week 5

Arm	Measure	Group	Value (MEAN)	Dispersion
With C-brace	Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis	Unaffected Hip flexion-extension	45.31 degrees	Standard Deviation 10.21
With C-brace	Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis	Affected Hip flexion-extension	33.98 degrees	Standard Deviation 10.03
With C-brace	Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis	Affected Hip abduction-adduction	9.34 degrees	Standard Deviation 3.04
With C-brace	Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis	Affected Hip internal-external rotation	21.25 degrees	Standard Deviation 14.45
With C-brace	Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis	Affected Knee flexion-extension	34.51 degrees	Standard Deviation 16.55
With C-brace	Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis	Affected Knee abduction-adduction	7.72 degrees	Standard Deviation 1.77
With C-brace	Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis	Affected Knee internal-external rotation	16.26 degrees	Standard Deviation 9.53
With C-brace	Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis	Affected Ankle flexion-extension	13.51 degrees	Standard Deviation 7.73
With C-brace	Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis	Affected Ankle abduction-adduction	6.06 degrees	Standard Deviation 4.33
With C-brace	Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis	Affected Ankle internal-external rotation	8.36 degrees	Standard Deviation 7.09
With C-brace	Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis	Unaffected Hip abduction-adduction	8.74 degrees	Standard Deviation 3.11
With C-brace	Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis	Unaffected Hip internal-external rotation	14.82 degrees	Standard Deviation 6.41
With C-brace	Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis	Unaffected Knee flexion-extension	53.71 degrees	Standard Deviation 7.64
With C-brace	Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis	Unaffected Knee abduction-adduction	10.30 degrees	Standard Deviation 4.79
With C-brace	Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis	Unaffected Knee internal-external rotation	11.83 degrees	Standard Deviation 3.11
With C-brace	Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis	Unaffected Ankle flexion-extension	21.83 degrees	Standard Deviation 6.36
With C-brace	Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis	Unaffected Ankle abduction-adduction	6.85 degrees	Standard Deviation 1.75
With C-brace	Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis	Unaffected Ankle internal-external rotation	12.64 degrees	Standard Deviation 4.2

Primary

Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis

During the 10 Meter Walk Test (10MWT), infrared light emitting diode markers will be attached to bilateral lower extremities. The marker data will be recorded using the NDI Optotrak Certus motion capture system. Marker data will be processed using custom Matlab program to determine lower extremity joint excursion. Joint excursion is the range of motion of a particular joint, and the range of motion is reported in degrees. After stroke, one side of the body is affected, and joint excursion for various joint angles (of hip, knee, and ankle) are reported for both sides of the body (affected side of body and unaffected side of body).

Time frame: week 9

Arm	Measure	Group	Value (MEAN)	Dispersion
With C-brace	Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis	Affected Hip flexion-extension	38.80 degrees	Standard Deviation 11.26
With C-brace	Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis	Affected Hip abduction-adduction	9.03 degrees	Standard Deviation 3.55
With C-brace	Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis	Affected Hip internal-external rotation	22.75 degrees	Standard Deviation 15.71
With C-brace	Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis	Affected Knee flexion-extension	34.93 degrees	Standard Deviation 17.02
With C-brace	Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis	Affected Knee abduction-adduction	7.92 degrees	Standard Deviation 2.93
With C-brace	Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis	Affected Knee internal-external rotation	16.18 degrees	Standard Deviation 7.71
With C-brace	Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis	Affected Ankle flexion-extension	15.91 degrees	Standard Deviation 6.82
With C-brace	Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis	Affected Ankle abduction-adduction	6.82 degrees	Standard Deviation 5.51
With C-brace	Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis	Affected Ankle internal-external rotation	7.55 degrees	Standard Deviation 6.01
With C-brace	Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis	Unaffected Hip flexion-extension	46.20 degrees	Standard Deviation 10.79
With C-brace	Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis	Unaffected Hip abduction-adduction	9.86 degrees	Standard Deviation 3.34
With C-brace	Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis	Unaffected Hip internal-external rotation	14.99 degrees	Standard Deviation 5.25
With C-brace	Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis	Unaffected Knee flexion-extension	55.55 degrees	Standard Deviation 7.64
With C-brace	Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis	Unaffected Knee abduction-adduction	12.06 degrees	Standard Deviation 5.83
With C-brace	Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis	Unaffected Knee internal-external rotation	12.78 degrees	Standard Deviation 4.32
With C-brace	Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis	Unaffected Ankle flexion-extension	21.88 degrees	Standard Deviation 4.78
With C-brace	Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis	Unaffected Ankle abduction-adduction	7.85 degrees	Standard Deviation 2.17
With C-brace	Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis	Unaffected Ankle internal-external rotation	13.16 degrees	Standard Deviation 5.42

Primary

Metabolic Expenditure During Walking

Change in metabolic expenditure during walking will be indicated by energy expenditure. Energy Expenditure will be measured by the K4 b2 Cosmed as follows: Oxygen cost will be calculated from oxygen consumption as the product of gait speed and body weight. Oxygen consumption will be collected on a breath-by-breath basis measured by a portable metabolic system (K4 b2 Cosmed). Prior to the testing, the system will be calibrated using room air and reference gas mixture. During the testing, the subject will wear a face mask and a heart rate monitor at all times and will be asked to breathe normally.

Time frame: week 9

Population: Data were not collected for 2 participants.

Arm	Measure	Value (MEAN)	Dispersion
With C-brace	Metabolic Expenditure During Walking	0.03 millilters/kilogram/minute (mL/kg/min	Standard Deviation 0.01

Primary

Metabolic Expenditure During Walking

Time frame: week 5

Population: Data were not collected for 2 participants.

Arm	Measure	Value (MEAN)	Dispersion
With C-brace	Metabolic Expenditure During Walking	0.03 millilters/kilogram/minute (mL/kg/min)	Standard Deviation 0.02

Secondary

Aerobic Capacity as Assessed by Peak VO₂ Per Kilogram Body Weight During the Six-minute Walk Test (6MWT)

The participant will perform the 6MWT, in which the participant will walk as far as possible in six minutes. During the 6MWT, the peak volume of oxygen consumed per minute (peak VO₂) will be will be measured by a portable metabolic system. Data are reported as peak volume of oxygen (in milliliters) consumed per kilogram bodyweight per minute per meter walked \[milliliters/kilogram/minute/meter (mL/kg/min/m)\].

Time frame: week 5

Population: Data for this outcome measure were not collected for 2 participants.

Arm	Measure	Value (MEAN)	Dispersion
With C-brace	Aerobic Capacity as Assessed by Peak VO₂ Per Kilogram Body Weight During the Six-minute Walk Test (6MWT)	0.030 mL/kg/min/m	Standard Deviation 0.015

Secondary

Aerobic Capacity as Assessed by Peak VO₂ Per Kilogram Body Weight During the Six-minute Walk Test (6MWT)

Time frame: week 9

Arm	Measure	Value (MEAN)	Dispersion
With C-brace	Aerobic Capacity as Assessed by Peak VO₂ Per Kilogram Body Weight During the Six-minute Walk Test (6MWT)	0.030 mL/kg/min/m	Standard Deviation 0.013

Secondary

Aerobic Capacity as Assessed by Peak VO₂ Per Kilogram Body Weight During the Six-minute Walk Test (6MWT)

The participant will perform the 6MWT, in which the participant will walk as far as possible in six minutes. During the 6MWT, the peak volume of oxygen consumed per minute (peak VO₂) will be measured by a portable metabolic system. Data are reported as peak volume of oxygen (in milliliters) consumed per kilogram bodyweight per minute per meter walked \[milliliters/kilogram/minute/meter (mL/kg/min/m)\].

Time frame: week 0

Arm	Measure	Value (MEAN)	Dispersion
With C-brace	Aerobic Capacity as Assessed by Peak VO₂ Per Kilogram Body Weight During the Six-minute Walk Test (6MWT)	0.033 mL/kg/min/m	Standard Deviation 0.015

Secondary

Change in Ankle Dorsiflexors Strength as Assessed by Dynamometry

Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as ankle dorsiflexors.

Time frame: week 0, week 9