Biofeedback to Increase Propulsion During Walking After Stroke

NCT02667392 | Completed Phase 1 Results

• 1 other identifier: N2051-P
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke; Gait; Walking; Rehabilitation; Exercise; Exercise Therapy; Physical Therapy Modalities; Exercise Movement Techniques

Outcome Measures

Primary Outcomes (1)

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

  The propulsive impulse will be derived from the time integral of the positive anterior-posterior ground reaction force for the paretic leg normalized to Body Weight.

  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 (10)

• Change From Baseline in Peak Hip Flexion Range of Motion, in Degrees, of the Paretic Leg From Pre- to Post-intervention

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

• Change From Baseline in Stride Time From Pre to Post-intervention.

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

• Change From Baseline in Distance Covered During the Six Minute Walk Test From Pre- to Post-intervention

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

• Change From Baseline in the Functional Gait Assessment Score From Pre- to Post-intervention

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

• Change From Baseline in the Modified Falls Efficacy Scale From Pre- to Post-intervention

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

Study Arms (2)

Biofeedback Group

EXPERIMENTAL

Participants will wear a pressure-sensitive insole inside the shoe of their paretic limb. An auditory tone will sound when participants have provided sufficient load to active the pressure-sensitive in-sole.

Procedure: Gait Training with Biofeedback

Verbal Feedback Group

ACTIVE COMPARATOR

Participants will receive verbal feedback from a physical therapist regarding the amount of loading they are exerting on their paretic limb.

Procedure: Gait Training with Verbal Feedback

Interventions

Gait Training with Biofeedback PROCEDURE

Intervention (12, 60-minute sessions, 3X/week for four weeks) will occur in an outpatient research setting. Participants will be supervised by a licensed physical therapist and wear a gait belt during all activities. 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 bouts. This is the typical length and intensity of outpatient rehabilitation sessions for ambulatory patients discharged from inpatient rehabilitation. Biofeedback Group: Biofeedback (external-focus feedback) will be provided as an adjuvant to therapist-provided feedback during the intervention. Participants will be instructed that a tone will sound when they "push off with their (paretic) leg to swing it forward" when the participant-specific pre-programmed threshold is exceeded.

Biofeedback Group

Gait Training with Verbal Feedback PROCEDURE

Intervention (12, 60-minute sessions, 3X/week for four weeks) will occur in an outpatient research setting. Participants will be supervised by a licensed physical therapist and wear a gait belt during all activities. 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 bouts. This is the typical length and intensity of outpatient rehabilitation sessions for ambulatory patients discharged from inpatient rehabilitation. Verbal Feedback Group: Therapist-provided internal-focus feedback ("directed towards components of body movement") will be used to instruct participants on achieving and/or maintaining appropriate movement patterns that contribute to propulsion generation.

Verbal Feedback Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of stroke
• \> 6 months \< 5 years post-stroke onset
• Medically stable
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

North Florida/South Georgia Veterans Health System, Gainesville, FL

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Stroke; Motor Activity

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Results Point of Contact

• Title: Dr. Dorian Rose
• Organization: VAORD

dorian.rose@va.gov; dkrose@phhp.ufl.edu

352-376-1611

Study Officials

• Dorian Kay Rose, PhD MS BS

  North Florida/South Georgia Veterans Health System, Gainesville, FL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Parallel: participants are assigned to one of two or more groups in parallel for the duration of the study.

Study Record Dates

• First Submitted: January 19, 2016
• First Posted: January 28, 2016
• Study Start: October 2, 2017
• Primary Completion: September 16, 2019
• Study Completion: September 30, 2019
• Last Updated: February 21, 2021
• Results First Posted: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)