Phase 1
N=11
Biofeedback to Increase Propulsion During Walking After Stroke
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT02667392 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Change From Baseline in Forward Propulsion of the Paretic Limb From Pre- to Post-intervention — 0.00 Newtons . seconds/Body Weight — p=0.77
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Gait Training with Biofeedback (Procedure); Gait Training with Verbal Feedback (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Forward Propulsion of the Paretic Limb From Pre- to Post-intervention |
0.00 | 0.77 |
| SECONDARY Change From Baseline in Peak Hip Flexion Range of Motion, in Degrees, of the Paretic Leg From Pre- to Post-intervention |
1.5 | 0.61 |
| SECONDARY Change From Baseline in Stride Time From Pre to Post-intervention. |
0.1 | 0.28 |
| SECONDARY Change From Baseline in Distance Covered During the Six Minute Walk Test From Pre- to Post-intervention |
44 | 0.002 sig |
| SECONDARY Change From Baseline in the Functional Gait Assessment Score From Pre- to Post-intervention |
2.1 | 0.02 sig |
| SECONDARY Change From Baseline in the Modified Falls Efficacy Scale From Pre- to Post-intervention |
0.8 | 0.03 sig |
| SECONDARY Change From Baseline in Paretic Limb Step Time From Pre- to Post-intervention. |
.04 | 0.55 |
| SECONDARY Change From Baseline in Paretic Limb Stride Length From Pre to Post-intervention. |
.05 | 0.0089 sig |
| SECONDARY Change From Baseline in Paretic Limb Step Length From Pre to Post-intervention. |
.01 | 0.73 |
| SECONDARY Change From Baseline in Paretic Limb Step Width From Pre to Post-intervention. |
0.0 | 0.81 |
| SECONDARY Change From Baseline in Gait Speed From Pre to Post-intervention. |
0.14 | 0.02 sig |
Summary
Approximately 15,000 Veterans are hospitalized for stroke each year with new cases costing an estimated $111 million for acute inpatient, $75 million for post-acute inpatient, and $88 million for follow-up care over 6 months post-stroke. Rehabilitation of walking ability contributes to these costs. To "walk again" is the number one stated goal for Veterans who have had a stroke. Teaching patients post-stroke to use their weak leg while they are regaining walking function and to not compensate by over-using their strong leg is necessary to restore safe, efficient walking ability. This project will determine if providing biofeedback (an audible tone) from pressure-sensitive shoe insole sensors, that encourage use of the weaker leg during walking training, in addition to therapists' feedback, will help Veterans regain use of their weak leg, improve their endurance and improve their balance when walking in challenging environments.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of stroke
- > 6 months non-paretic step length)
- this asymmetry has been determined to be correlated with minimal propulsive force of the paretic leg4
- Unilateral lower extremity paresis confirmed by a score of 25
- ankle plantar flexion contracture > 15
Data sourced from ClinicalTrials.gov (NCT02667392). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.