Clinical trial NCT02667392: Biofeedback to Increase Propulsion During Walking After Stroke
Official title: Biofeedback to Increase Propulsion During Walking After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stroke
Keywords: Stroke
Gait
Walking
Rehabilitation
Exercise
Exercise Therapy
Physical Therapy Modalities
Exercise Movement Techniques
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-01-28
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel: participants are assigned to one of two or more groups in parallel for the duration of the study.
Primary purpose: TREATMENT

Brief 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.

Detailed description: Background/Purpose: Approximately 15,000 Veterans are hospitalized for stroke each year. Impairments of motor control and the subsequent functional limitations in ambulation are the most common manifestations and regaining the ability to walk is the number one stated goal of Veteran stroke survivors. Forward propulsion of the body's center of mass is a cardinal feature of gait that depends on the generation of appropriate anterior-posterior ground reaction forces. Decreased propulsive force generation by the paretic limb of stroke survivors has been identified through both simulation and cross-sectional studies as a major contributor to walking dysfunction. Extrinsic verbal feedback from a therapist is the standard approach used during gait retraining to improve propulsion generation. However, this key component of gait is not directly observable by therapists and patients are often unable to sense propulsion generation due to impaired intrinsic feedback, specifically deficits in somatosensation and proprioception, hindering recovery of paretic propulsion and compromising walking function. The objective of this study is to provide preliminary evidence that biofeedback as an adjuvant to therapists' verbal feedback will improve propulsion and enhance walking function for Veterans post-stroke.

Subjects: Thirty individuals \> 6-months post-stroke will participate. Additional study criteria include: 1) Ambulation of household distances without physical assistance to advance or support the paretic leg; 2) Unilateral leg paresis confirmed by a score of \< 32 on the Fugl-Meyer Motor Assessment; 3) Step length asymmetry (paretic \> non-paretic step length); 4) Ambulation without an assistive or orthotic device.

Methods: Participants will be randomized to either an experimental group that will train with propulsion biofeedback from commercially available pressure-sensitive insole sensors (Biofeedback group; n=15) or a control group that will train with standard therapist-provided verbal feedback alone (Standard group; n=15). The 12 session (3X/week for 4 weeks) gait training intervention will be delivered by a physical therapist-led team. For participants in the Biofeedback group, prior to the first intervention session, the baseline amount of pressure exerted by the paretic forefoot during late stance will be determined. The insole area underlying the forefoot will then be calibrated to produce a tone when pressure exceeds 5% of this baseline pressure. This threshold will be progressively increased at regular intervals throughout the intervention period to ensure participants are training at their challenge-point to improve propulsion of the paretic limb. An insole of similar thickness will be worn in the shoe of the non-paretic leg for symmetry and comfort but will not produce a tone during the intervention. Those in the Standard group will not wear insoles during intervention but will receive verbal feedback alone regarding propulsion of the paretic limb during gait training. Therapist-provided verbal feedback will be used to instruct participants on achieving and/or maintaining appropriate movement patterns that contribute to propulsion generation. For both groups, the therapist will choose from a standardized bank of gait activities, suitable to each participant's ability level. The goal for total walking time for each session will be 50 minutes: 5, 10-minute bouts with a 2-minute rest between each bout.

Outcome Measures: Paretic limb propulsion is the primary outcome measure. Secondary measures include the Six Minute Walk Test, Functional Gait Assessment, Fall Self-Efficacy, temporal-distance gait measures and gait kinematics, all of which will be measured pre- and post-intervention.

Data Analysis Plan: Descriptive statistics will be provided for all outcome measures. To identify the effect of the intervention, differences between the pre- and post-training assessment within each group (i.e. change scores) will be calculated. To test the hypotheses, the investigators will apply independent sample t-tests to the change scores of the Biofeedback and Standard group. Hypothesis testing will be conducted at a two-sided p \< 0.05 level.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
Secondary outcomes:
measure: Change From Baseline in Peak Hip Flexion Range of Motion, in Degrees, of the Paretic Leg 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.
measure: Change From Baseline in Stride Time 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.
measure: Change From Baseline in Distance Covered During the Six Minute Walk Test 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.
measure: Change From Baseline in the Functional Gait Assessment Score 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.
measure: Change From Baseline in the Modified Falls Efficacy Scale 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.
measure: Change From Baseline in Paretic Limb Step Time 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.
measure: Change From Baseline in Paretic Limb Stride Length 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.
measure: Change From Baseline in Paretic Limb Step Length 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.
measure: Change From Baseline in Paretic Limb Step Width 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.
measure: Change From Baseline in Gait Speed 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.
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: North Florida/South Georgia Veterans Health System, Gainesville, FL
state: Florida
Study officials:
affiliation: North Florida/South Georgia Veterans Health System, Gainesville, FL
name: Dorian Kay Rose, PhD MS BS
role: PRINCIPAL_INVESTIGATOR
References: