CompletedPhase 1

Biofeedback to Increase Propulsion During Walking After Stroke

United States11 participantsStarted 2017-10-02

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of stroke * \> 6 months \< 5 years post-stroke onset * Medically stable * 18-80 years of age * Impaired lower extremity sensation confirmed by a score of \< 12 on the Fugl-Meyer Sensory Assessment,20 * Community-dwelling * Step length asymmetry (paretic step length \> 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 \< 32 on the Fugl-Meyer Motor Assessment,20 * Able to ambulate without an orthotic device * Able to ambulate without an assistive device * Ambulation of household distances without physical assistance to advance or support paretic lower extremity Exclusion Criteria: * Presence of a neurological condition other than stroke * Pain upon ambulation * Receiving physical therapy services for mobility and/or gait * Severe arthritis or orthopedic problems that limit passive ranges of motion * knee flexion contracture of -10 , knee flexion range of motion (ROM) \< 90 * hip flexion contracture \> 25 * ankle plantar flexion contracture \> 15

What they're measuring

Change From Baseline in Forward Propulsion of the Paretic Limb From Pre- to Post-intervention

Timeframe: Pre-intervention (prior to 1st intervention session) and Post-intervention (after the final (12th intervention session), approximately 4 weeks after entering the study.

Trial details

NCT IDNCT02667392

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2019-09-16

Results submitted2020-10-30