Parkinson's Disease
Conditions
Keywords
Parkinson's disease, ankle foot orthosis (AFO), gait
Brief summary
The purpose of this study is to investigate the impact of a specifically designed ankle foot orthosis (AFO, hinged, with Tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG) and walking endurance, in select individuals living with Parkinson's disease.
Detailed description
This study will be 10 weeks long. Following fitting with unilateral or bilateral custom-fabricated AFOs the subject will participate in 4 gait training sessions which will be at weeks 1, 2, and 7. Each training session will be 45-60 minutes in duration. Various outcome measures will be completed at the following times: time of consent (T1), treatment 1 at time of brace delivery (T2), week 5 (T3), and week 10 (T4). Subjects will be closely monitored throughout the 10 week study and will be unenrolled by self-request or the following medical reasons: 1. New diagnosis with direct consequences affecting gait training, 2. Inability to tolerate the study AFO(s).
Interventions
DEVICEAnkle foot orthosis
Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program.
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of Parkinson's Disease * Between the ages of 50 and 75 * Ability to walk 150 feet independently over level surfaces with or without an assistive device * Stable medication usage for the duration of the study (10 weeks) * Obvious gait dysfunction (Observational Gait Analysis) * Score of greater than 22 on the Short Orientation-Memory-Concentration Test
Exclusion criteria
* Body mass index of greater than 35 * Dorsiflexion range of motion less than neutral (90 degrees) * Any other uncontrolled health condition for which gait training is contraindicated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Step Length by Means of Computerized Gait Analysis From Initial to Final Testing | Done at time of enrollment in the study, i.e. baseline and 10 weeks post enrollment | Participants will be asked to walk on a 12-16 foot long vinyl pad placed on the floor. The mat will record and analyze step length. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Change in Electromyography of Key Lower Extremity Muscles From Initial to Final Testing | Done at time of enrollment in the study, i.e. baseline and week 10 post enrollment. | Surface electromyography will be done on key muscles in the lower extremity (quads, anterior tibialis, gastrocnemius) during computerized gait assessment. Changes in EMG activity include things such as increases in amplitude or timing that might indicate increases in strength or motor learning as a result of wearing the ankle foot orthosis. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Walking Endurance by Use of 6-Minute Walk Test From Initial to Final Testing | Done at time of enrollment in the study, i.e. baseline and week 10 post enrollment | Each participant will be asked to walk at a self-selected velocity on level surfaces for 6 minutes. They will be allowed to use assistive devices if necessary. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ankle Foot Orthosis Fitting All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings.
Ankle foot orthosis: Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program. | 4 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Ankle Foot Orthosis Fitting |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Age, Continuous | 68 years STANDARD_DEVIATION 5.22 |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
Change in Step Length by Means of Computerized Gait Analysis From Initial to Final Testing
Participants will be asked to walk on a 12-16 foot long vinyl pad placed on the floor. The mat will record and analyze step length.
Time frame: Done at time of enrollment in the study, i.e. baseline and 10 weeks post enrollment
Population: step length was analyzed from the GAITRite
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ankle Foot Orthosis Fitting | Change in Step Length by Means of Computerized Gait Analysis From Initial to Final Testing | 6.7 cm | Standard Deviation 2.77 |
Secondary
Number of Participants With a Change in Electromyography of Key Lower Extremity Muscles From Initial to Final Testing
Surface electromyography will be done on key muscles in the lower extremity (quads, anterior tibialis, gastrocnemius) during computerized gait assessment. Changes in EMG activity include things such as increases in amplitude or timing that might indicate increases in strength or motor learning as a result of wearing the ankle foot orthosis.
Time frame: Done at time of enrollment in the study, i.e. baseline and week 10 post enrollment.
Population: EMG data was analyzed from 3 of the 4 participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ankle Foot Orthosis Fitting | Number of Participants With a Change in Electromyography of Key Lower Extremity Muscles From Initial to Final Testing | 0 participants |
Other Pre-specified
Change in Walking Endurance by Use of 6-Minute Walk Test From Initial to Final Testing
Each participant will be asked to walk at a self-selected velocity on level surfaces for 6 minutes. They will be allowed to use assistive devices if necessary.
Time frame: Done at time of enrollment in the study, i.e. baseline and week 10 post enrollment
Population: data from 3 of the 4 participants was analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ankle Foot Orthosis Fitting | Change in Walking Endurance by Use of 6-Minute Walk Test From Initial to Final Testing | .2 meters | Standard Deviation 0 |