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| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP-OP230011 | Other Grant/Funding Number | Department of Defence |
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| Name | Class |
|---|---|
| University of Washington | OTHER |
| Chapman University | OTHER |
| United States Department of Defense | FED |
| National Institutes of Health (NIH) |
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The purpose of this research is to determine the feasibility of an uneven terrain walking program for lower limb prosthesis users. The training is designed to induce step-to-step variability during walking within a safe environment, with the aim of improving walking skill and confidence.
Despite advances in the technology for artificial limbs (prostheses), falling and the fear of falling continue to be barriers to mobility for many lower limb prosthesis users after their initial rehabilitation. The loss of ability and confidence in pursuing everyday tasks negatively impacts quality of life, and ongoing physical and mental health. This study will test and improve a rehabilitation training intervention involving walking on uneven ground to improve walking skill and confidence in lower limb prosthesis users.
Lower limb prosthesis users will be recruited. Participants will be allocated randomly to receive either intervention A: training on a flat surface, or intervention B: training on an uneven surface. Depending on their ability and confidence, participants will complete the walking practice either on a treadmill or on a mat with an identical surface pattern. The walking practice will take place three times per week for four weeks. As each participant improves their ability, training tasks will be made more difficult by limiting handrail use, by increasing walking speed, and, for intervention B, also by making the walking surface more uneven.
The objectives of this pilot study are to evaluate adherence and refine the training protocols in preparation for a definitive trial that will inform rehabilitation practices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flat terrain training | Active Comparator | Walking on a standard, flat treadmill or mat. |
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| Uneven terrain training | Experimental | Walking on an uneven terrain treadmill or mat. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flat terrain locomotor training | Other | The training will be comprised of up to 12 sets of 2-min continuous walking on a level treadmill or mat, interspersed with rest breaks of at least one minute. Training will be completed three times per week for four weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Session adherence | Percentage of planned sessions attended, per participant. | Through study completion, over 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| L-test time | Time to complete L-test, in s. Participant rises from a chair and guided by cones, walks 10m forward, turns 90 degrees, walks a further 10m, turns 180 degrees, then follows the same path back to the chair and sits. Result from a single test following one practice trial is recorded. | Pre-intervention, within 5 days post intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jenny A Kent, PhD, CSci | Contact | 7028955949 | jenny.kent@unlv.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jenny A Kent, PhD, CSci | University of Nevada, Las Vegas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nevada Las Vegas | Recruiting | Las Vegas | Nevada | 89154 | United States |
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| NIH |
Feasibility study incorporating a single-blinded Phase I clinical trial with a parallel groups design, involving two treatment conditions: uneven terrain training (UT) and flat terrain (FT) training. Participants will be allocated randomly to UT and FT arms in a 6:1 ratio.
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| Uneven terrain locomotor training | Other | The training will be comprised of up to 12 sets of 2-min continuous walking on an uneven terrain treadmill or mat, interspersed with rest breaks of at least one minute. Training will be completed three times per week for four weeks. |
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| Activities-specific Balance Confidence Scale summary score | 16-item self report measure recording confidence in performing activities during daily life that require balance, on numerical ratings scale, recorded as a percentage (out of 100). | Pre-intervention, within 5 days post intervention |
| Average daily activity | Mean number of steps per day over 7 days, collected using ankle worn activity monitor. | Pre-intervention, within 5 days post intervention |
| Four Square Step Test time | Time to complete forwards, lateral and backwards stepping pattern, in s. | Pre-intervention, within 5 days post intervention |
| Single leg stand time | Time standing on one leg up to a maximum of 20s, in s. | Pre-intervention, within 5 days post intervention |
| Two-minute walk test distance | Walking distance traveled in two minutes, in m. | Pre-intervention, within 5 days post intervention |
| Protocol acceptability | Likert scale questions and short answer questions to determine acceptability of protocol to participants, assessed qualitatively. | End of intervention week 4 |
| Recruitment feasibility - recruitment rate | Number of participants recruited within one year | From start of recruitment period, to 12 month time point. |
| Recruitment feasibility - participating clinics | Number of clinics from which at least one participant is recruited. | Through study completion, from start of recruitment period, to end of recruitment period or 30 month time point, whichever is sooner. |
| Recruitment feasibility - sample characteristics | Sample characteristics of all participants enrolled in the study, regardless of completion. | Through study completion, from start of recruitment period, to end of recruitment period or 30 month time point, whichever is sooner. |
| Activity data evaluation | Completeness and quality of activity monitor data, measured as number of days with valid (non-erroneous) monitoring data. | Throughout activity monitoring period, over 2 weeks |
| Maximum relative variability of lateral trunk velocity during uneven terrain in comparison to overground walking | Medial-lateral trunk variability will be quantified during each bout of walking during each session. The maximum relative variability will be calculated as the difference in variability (standard deviation) of peak per-step lateral trunk velocity during UT walking sessions relative to that of overground walking, in m/s. | Through study completion, over 4 weeks |
| Contour depth at maximum relative variability | Terrain contour depth at which the maximum relative variability was recorded, in m. | Through study completion, over 4 weeks |
| Maximum relative step width variability during uneven terrain in comparison to overground walking | Step width variability will be quantified during each bout of walking during each session. The maximum relative variability will be calculated as the difference in variability (standard deviation) of step width during UT walking sessions relative to that of overground walking, in m. | Through study completion, over 4 weeks |
| Prosthesis Users Survey of Mobility t-score | 12-item self report tool measuring prosthesis users' mobility. | Pre-intervention, within 5 days post intervention |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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