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Upper Limb Loss Perturbation Response

Locomotor Response of Persons With Upper Limb Loss to Treadmill Perturbations

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04274218
Enrollment
20
Registered
2020-02-18
Start date
2020-12-11
Completion date
2022-06-30
Last updated
2024-11-14

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

Conditions

Amputation

Keywords

Stability, Locomotion, Motor Control, Trip, Falls, Upper Limb Loss, Prosthesis, Arm

Brief summary

Recent investigations have suggested that persons with upper limb loss experience a high prevalence of falls with a quarter of reported falls resulting from a trip. Moreover, studies indicate that missing part of an arm may negatively impact balance and that use of a prosthesis exacerbates this problem. While the investigators are beginning to understand the effects of upper limb loss on balance, the understanding of how Veterans with upper limb loss respond to walking disturbances is incomplete. Therefore, the aims of this study are to observe the effects of upper limb loss and wearing a prosthesis on the preparation and recovery of Veterans who trip during walking. The investigators plan to use unique treadmill technology to deliver controlled, yet unexpected, perturbations to Veterans with upper limb loss and non-amputee controls, and assess walking stability through body dynamics. Results from this study will help us understand why Veterans with upper limb loss fall as a critical first step to addressing this problem through balance-targeted interventions that are integrated into patient care.

Detailed description

The primary aim of this pilot study is to characterize the proactive and reactive locomotor response of Veterans with upper limb loss (ULL) to a trip during walking. The investigators' recent VA-funded investigations have suggested that persons with ULL experience a high prevalence of falls and demonstrate postural control mechanisms that may impair stability. Specifically, nearly half of individuals with ULL at or proximal to the wrist level experience at least one fall per year and almost a third will experience two or more falls. Further, use of a prosthesis increases the likelihood of falling by six times, 25% of reported falls resulted from tripping, and nearly a third of individuals who experience a fall suffer a fall-related injury. Falls can have considerable economic burden on the VHA and lead to long-term diminished quality of life. The investigators' biomechanical studies suggest that persons with unilateral ULL display greater postural sway during standing than able-bodied individuals which increases when wearing a prosthesis, and right/left asymmetry in locomotor stability dynamics that may increase the risk of falling toward the impaired limb side and during sound limb side strides. These findings emphasize the need for additional research to better understand the mechanisms Veterans with ULL use to control balance and how wearing a prosthesis affects these strategies. As the investigators' previous research was concerned with steady-state characterization of postural control, the investigators now plan to build on this work by studying the effects of ULL and wearing a prosthesis on locomotor stability when responding to a trip disturbance during walking. In this context, locomotor stability is defined as the ability to recover from a perturbation and return to steady-state gait. The investigators will address the study aims by analyzing trip-induced proactive and reactive locomotor strategy differences in two study comparisons: 1) Veterans with unilateral transradial level ULL against matched able-bodied controls (with and without one arm bound), and 2) Veterans with unilateral transradial ULL when wearing their customary prosthesis against not wearing their prosthesis. Controlled, yet unexpected, simulated trips will be delivered through the investigators' custom-built treadmill which permits programmable belt velocity disturbances and allows participants to continue walking following recovery. The investigators will characterize the proactive and reactive locomotor stability mechanisms through a set of biomechanical (angular momentum, arm and trunk kinematics) variables. Biomechanical variables will be quantified using an optical motion capture system. The investigators expect that Veterans with ULL will demonstrate altered locomotor stability mechanisms compared to controls, and these differences will exist between wearing and not wearing their customary prosthesis. Results from this study will help us characterize the underlying mechanisms of locomotor stability in Veterans with ULL and identify the factors associated with their increased prevalence of trip-related falls. Such knowledge is a critical first step to addressing this public health problem through stability-targeted rehabilitation interventions aimed at reducing falls, fall-related injuries, and associated VHA costs in this Veteran patient group. The investigators will use the outcomes from this pilot study to guide future VA Merit Award proposals to develop and assess physical training intervention methods and wearable and prosthetic technology to improve stability in Veterans with ULL. The VHA is an ideal venue to pursue this work as one of its main priorities is to elevate the standard-of-care for Veterans with limb loss.

Interventions

Participants from both cohorts will experience a simulated trip while walking on the treadmill. The trip is induced through a rapid acceleration and deceleration of the treadmill belt speed.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Masking description

No masking.

Intervention model description

Participants will receive a small treadmill belt disturbance while walking.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

Participant inclusion criteria for all participants include: * age between 18 and 65 years * normal or corrected vision * able to walk unassisted for 20 minutes without undue fatigue or health risks Additional inclusion criteria for participants with ULL include: * unilateral ULL at the transradial level * most recent major upper limb amputation occurred at least one year prior to study * residuum and amputated side in good condition (no scars, infections, pain, etc.) * habitual experience using an upper limb prosthesis for at least one year * a self-reported comfortable prosthetic suspension

Design outcomes

Primary

MeasureTime frameDescription
Whole-body Angular Momentum in Sagittal-plane; Momentum of the Body in the Sagittal Plane of Walking Progression1 hourWhole-body angular momentum is the momentum of all limb segments about the Body Center of Mass (BCoM) summed. Whole-body angular momentum is estimated in the sagittal plane, which is the plane of walking progression, and the range of this value is normalized to a person's body mass, height, and walking speed. Whole body angular momentum is minimized by the central nervous system to facilitate postural control. For this study, whole body angular momentum range was averaged across the 12 perturbation trials and then across all participants. To note, the reported whole body angular momentum values are the relative increase from baseline to perturbation recovery that are all measured in the same session. There are no additional sessions as the baseline whole body angular momentum reflects those values before the perturbation trials.

Secondary

MeasureTime frameDescription
Shoulder Angle Flexion-extension Range1 hourRange-of-motion for shoulder joint angle flexion-extension of the impaired or non-dominant arm (Deg) during perturbation recovery; Dynamics used for postural control to regulate and reduce whole-body angular momentum during trip response.
Trunk Flexion Angle1 hourMaximum flexion angle (degrees) of the trunk during perturbation recovery.
Trunk Flexion Velocity1 hourMaximum trunk flexion velocity (deg/s) during perturbation recovery

Countries

United States

Participant flow

Recruitment details

10 participants with upper limb absence and 10 healthy controls were screened for eligibility between December 1 2020 and February 10 2022. Individuals with upper limb loss were recruited from clinics providing prosthetics care and education programs for prosthetics. Healthy controls were recruited from the Chicago community.

Pre-assignment details

All 20 participants agreed to participate and completed the study protocol.

Participants by arm

ArmCount
Healthy Controls
Healthy controls without limb loss will receive a treadmill belt disturbance while walking. Able-bodied individuals will walk with both arms free and with one arm bound.
10
Upper Limb Absence
Individuals with upper limb loss between the wrist and elbow will receive a treadmill belt disturbance while walking with and without their prosthesis.
10
Total20

Baseline characteristics

CharacteristicUpper Limb AbsenceTotalHealthy Controls
Age, Continuous44 years
STANDARD_DEVIATION 15
44 years
STANDARD_DEVIATION 15
44 years
STANDARD_DEVIATION 16
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants2 Participants2 Participants
Race (NIH/OMB)
More than one race
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
9 Participants17 Participants8 Participants
Sex: Female, Male
Female
4 Participants8 Participants4 Participants
Sex: Female, Male
Male
6 Participants12 Participants6 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 100 / 100 / 100 / 10
other
Total, other adverse events
0 / 100 / 100 / 100 / 10
serious
Total, serious adverse events
0 / 100 / 100 / 100 / 10

Outcome results

Primary

Whole-body Angular Momentum in Sagittal-plane; Momentum of the Body in the Sagittal Plane of Walking Progression

Whole-body angular momentum is the momentum of all limb segments about the Body Center of Mass (BCoM) summed. Whole-body angular momentum is estimated in the sagittal plane, which is the plane of walking progression, and the range of this value is normalized to a person's body mass, height, and walking speed. Whole body angular momentum is minimized by the central nervous system to facilitate postural control. For this study, whole body angular momentum range was averaged across the 12 perturbation trials and then across all participants. To note, the reported whole body angular momentum values are the relative increase from baseline to perturbation recovery that are all measured in the same session. There are no additional sessions as the baseline whole body angular momentum reflects those values before the perturbation trials.

Time frame: 1 hour

Population: Data collected for each participant during baseline and when recovering from the perturbation.

ArmMeasureValue (MEAN)Dispersion
Healthy Controls Arms FreeWhole-body Angular Momentum in Sagittal-plane; Momentum of the Body in the Sagittal Plane of Walking Progression0.025 Unitless (normalized)Standard Deviation 0.0006
Upper Limb Absence Without ProsthesisWhole-body Angular Momentum in Sagittal-plane; Momentum of the Body in the Sagittal Plane of Walking Progression0.031 Unitless (normalized)Standard Deviation 0.006
Healthy Controls One Arm BoundWhole-body Angular Momentum in Sagittal-plane; Momentum of the Body in the Sagittal Plane of Walking Progression0.027 Unitless (normalized)Standard Deviation 0.009
Upper Limb Absence With ProsthesisWhole-body Angular Momentum in Sagittal-plane; Momentum of the Body in the Sagittal Plane of Walking Progression0.028 Unitless (normalized)Standard Deviation 0.006
Secondary

Shoulder Angle Flexion-extension Range

Range-of-motion for shoulder joint angle flexion-extension of the impaired or non-dominant arm (Deg) during perturbation recovery; Dynamics used for postural control to regulate and reduce whole-body angular momentum during trip response.

Time frame: 1 hour

Population: Range of motion of shoulder flexion-extension of the impaired (individuals with upper limb absence) or non-dominant arm (healthy controls) during perturbation recovery.

ArmMeasureValue (MEAN)Dispersion
Healthy Controls Arms FreeShoulder Angle Flexion-extension Range36 DegreesStandard Deviation 18
Upper Limb Absence Without ProsthesisShoulder Angle Flexion-extension Range34 DegreesStandard Deviation 10
Healthy Controls One Arm BoundShoulder Angle Flexion-extension Range5 DegreesStandard Deviation 1
Upper Limb Absence With ProsthesisShoulder Angle Flexion-extension Range31 DegreesStandard Deviation 16
Secondary

Trunk Flexion Angle

Maximum flexion angle (degrees) of the trunk during perturbation recovery.

Time frame: 1 hour

Population: Controls with both arms free or one arm bound and persons with upper limb absence wearing or not wearing their prosthesis.

ArmMeasureValue (MEAN)Dispersion
Healthy Controls Arms FreeTrunk Flexion Angle9.9 DegreesStandard Deviation 3.1
Upper Limb Absence Without ProsthesisTrunk Flexion Angle10.1 DegreesStandard Deviation 2.7
Healthy Controls One Arm BoundTrunk Flexion Angle10.1 DegreesStandard Deviation 4.1
Upper Limb Absence With ProsthesisTrunk Flexion Angle10.2 DegreesStandard Deviation 2.7
Secondary

Trunk Flexion Velocity

Maximum trunk flexion velocity (deg/s) during perturbation recovery

Time frame: 1 hour

Population: Controls with both arms free or one arm bound and persons with upper limb absence with or without their prosthesis.

ArmMeasureValue (MEAN)Dispersion
Healthy Controls Arms FreeTrunk Flexion Velocity35.2 Degrees/secondStandard Deviation 6.3
Upper Limb Absence Without ProsthesisTrunk Flexion Velocity34.5 Degrees/secondStandard Deviation 9.3
Healthy Controls One Arm BoundTrunk Flexion Velocity37.2 Degrees/secondStandard Deviation 9.4
Upper Limb Absence With ProsthesisTrunk Flexion Velocity32.9 Degrees/secondStandard Deviation 10.8

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026