Biofeedback to Increase Propulsion During Walking After Stroke
Condition: Stroke
MeSH terms: Stroke
Intervention: Gait Training with Biofeedback; Gait Training with Verbal Feedback
Intervention description: 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.; 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.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel: participants are assigned to one of two or more groups in parallel for the duration of the study.
Masking: Single (Outcomes Assessor)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Stroke; Gait; Walking; Rehabilitation; Exercise; Exercise Therapy; Physical Therapy Modalities; Exercise Movement Techniques

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 < 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