Home-based FES Training in People With Chronic Stroke
ConditionChronic Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversity of Illinois at Chicago
About this trial
This project will examine the feasibility, safety and effect of home-based functional electrical stimulation (FES) applied to different lower limb muscles in combination with task-specific training on gait, balance and mobility in adults with chronic stroke. 30 individuals with chronic stroke will first undergo initial screening and baseline walking, mobility, balance and strength assessments in the laboratory. After determining their eligibility for the study, they will undergo 12-weeks of home-based FES and task-specific training. Following the initial screening (week 1) and pre-intervention assessment (week 2), participants will be trained in the lab for 6 sessions (week 3-4) for a FES home program and then given a FES home kit (FES device and an android tablet). Participants will then undergo home-training for 2 weeks (week 5-6) followed by mid-training assessment (week 7). Again, participants will undergo 4-weeks of home training (week 8-11) and final assessment at the end of training (week 12).
This project has the following specific aims:
Aim 1: To investigate the feasibility, safety and efficacy of 12-weeks of home-based FES and task-specific training in adults with chronic stroke.
Aim 2: To examine the effect of 12-weeks of home-based FES and task-specific training on mobility, gait and balance (anticipatory and reactive balance) in adults with chronic stroke.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age group: 18-90 years.
Presence of unilateral hemiparesis.
Onset of stroke (> 6 months).
Ability to walk independently with or without an assistive device for at least 300 ft.
Disqualifiers
Body weight more than 250 lbs.
Heel bone density measurement using an ultrasound device. Individuals classified as osteoporotic (i.e., with a T-score < -2) will be excluded.
Cognitive impairment (Montreal Cognitive assessment score <26/30)
Verbal Aphasia (i.e <71% score on Mississippi Aphasia Screening)
Trial design
Design model
Single group
Treatments tested in this trial
Functional Electrical Stimulation
Device12-weeks of training sessions that include initial screening and clinical assessment (Week 1-2), onsite training sessions (Week 3-4), home training sessions (Week 4-8). There will also be pre (Week 1), mid (Week 7) and post-training (Week 12) assessment. Each session will consist of a 10-minute warm-up session with 5-6 stretching exercises. Warm-up will be followed by a 30 minute training session comprising of mobility, balance and walking exercises with FES. This will be followed by a cool down session for 10-minutes comprising of 5-6 muscle stretches. The participant will first watch video of the each exercise on the android tablet and then perform the exercises.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Home-training with functional electrical stimulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Dynamic balance from baseline to mid and post-training
Berg Balance Scale is a 14-point scale that is widely used in the clinic and research settings to test dynamic balance in different populations. This outcome measure tests the balance during various daily living activities including sit to stand, transferring from bed to chair, reaching forward with an outstretched arm, placing alternating foot on stool amongst others. Out of a total score of 56, a score of less than 40 is considered to at moderate fall-risk in people with chronic stroke. A score more than 40 is considered as low to moderate fall-risk for participants to perform home activities. Hence, participants who score \>40 points on 56 will be qualified to transition to the independent home training sessions. Further, dynamic balance will also be assessed using the Limits-of-stability test. Here, the participant will be asked to reach multi-directional targets and their body's center of pressure excursion and movement velocity will be assessed.
Time frame
Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12)2
Change in Functional balance from baseline to mid and post-training
Mini-BESTest scale will be used to assess functional balance. This scale consists of 36-items which assess 6 balance control systems. This scale is a balance assessment tool testing dynamic and reactive balance with six components to assess 1) Biomechanical constraints 2) Stability limits/Verticality 3) Transitions/anticipatory balance 4) Reactive balance 5) Sensory orientation and 6) Stability in Gait
Time frame
Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12)3
Change in the Timed up and go test from baseline to mid and post-training
Assessed using The Timed Up and Go test, unit of assessment is seconds. The Timed Up and Go test requires the participant to stand up from a chair, walk 3 meters, turn around, come back and sit again "as quickly as possible." Lesser time indicates better functional mobility
Time frame
Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12)4
Change in the Four square step test from baseline to mid and post-training
Assessed via four square step test, unit of assessment is seconds. The four-square step test is used to assess coordination. Here, the participant is asked to step in a 4 square in clockwise and then anti-clockwise manner and the time to complete the test is recorded. Lesser time taken to complete the test indicates better functional mobility.
Time frame
Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12)Sponsors and contacts
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Source ClinicalTrials.gov