N/A
Completed N=19
Innovative Biofeedback Interface for Enhancing Stroke Gait Rehabilitation
Gait, Hemiplegic · Stroke
Source: ClinicalTrials.gov NCT04013971 ↗
Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcomePrimary: Peak AGRF — 99.1; 143.8; 95.6; 166.6 Newtons
Summary
This study will conduct a preliminary evaluation of and obtain user data on a novel game-based visual interface for stroke gait training. Study participants will complete one session comprising exposure to gait biofeedback systems in an order determined by randomization. Participants will be exposed to 2 types of biofeedback interfaces:
* newly developed game-based interface (projector screen display)
* traditional, non-game interface
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak AGRF |
99.1; 143.8; 95.6; 166.6 | — |
| PRIMARY Trailing Limb Angle (TLA) |
19.56; 22.52; 18.63; 24.22 | — |
| SECONDARY Likert Enjoyment/Boredom Scale Domain Scores |
5.57; 4.78; 6.29; 5.78; 6.57; 5.22 | — |
| SECONDARY NASA Task Load Index (NASA - TLX) |
7.98; 6.89; 9.76; 10.83 | — |
| SECONDARY Borg Rating of Perceived Exertion (RPE) Scale |
10.29; 8.67; 10.43; 10.11 | — |
| SECONDARY User Evaluation Questionnaire (UEQ) Score |
5.46; 5.19; 5.36; 5.41; 2.27; 2.69 | — |
Eligibility Criteria
Inclusion Criteria for Post-Stroke Participants:
- age 30 to 90 years
- chronic stroke (>6 months post stroke) affecting the right leg
- ambulatory with or without the use of a cane or walker
- able to walk for 2 minutes at the self-selected speed without an orthoses
- resting heart rate 40-100 beats per minute
Exclusion Criteria for Post-Stroke Participants:
- cerebellar signs (ataxic ("drunken") gait or decreased coordination during rapid alternating hand or foot movements)
- history of lower extremity joint replacement
- inability to communicate with investigators
- neglect/hemianopia, or unexplained dizziness in last 6 months
- neurologic conditions other than stroke
- orthopedic problems in the lower limbs or spine (or other medical conditions) that limit walking or cause pain during walking
Inclusion Criteria for Able-bodied Participants:
- age 18 to 90 years
- no history of neurologic disease
- no history of orthopedic disease or injury affecting the lower extremity
Exclusion Criteria for Able-bodied Participants:
- history of neurologic disease
- history of orthopedic disease or injury to the lower extremity in the past 6 months
- pain or discomfort during walking
- cardiovascular or medical condition affecting ability to exercise or walk
Data sourced from ClinicalTrials.gov (NCT04013971). 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. Informational only — not medical advice.