Home-based FES Training in People With Chronic Stroke

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Functional Electrical Stimulation

12-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.

Change in Dynamic balance from baseline to mid and post-training

Time frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12)

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.

Change in Functional balance from baseline to mid and post-training

Time frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12)

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

Change in the Timed up and go test from baseline to mid and post-training

Time frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12)

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

Change in the Four square step test from baseline to mid and post-training

Time frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12)

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.

Change in the 30-second chair stand test from baseline to mid and post-training

Time frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12)

Assessed via 30-second chair stand test, unit of assessment is number. The participant is asked to stand from a chair and sit down as fast as they can and as many times as they can and the number of repetitions is recorded. More repetitions indicate more functional mobility.

Change in functional reaching from baseline to mid and post-training

Time frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12)

This test requires the participant to reach forward with their arms stretched by moving their weight on their toes without bending their back or knees. Functional-reach test is used as an outcome to assess risk of falling.

Change in volitional balance via Sensory organization testing from baseline to mid and post-training

Time frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12)

Posturography for assessing balance six conditions (SOT): under condition 1 (eyes open), and condition 2 (eyes closed), both the platform and the surround remain immobilized. Under condition 3, the surround moves. Under condition 4, the platform moves and the surround remains fixed. Under condition 5, the platform moves while the subject keeps his/her eyes closed. Under condition 6, both the surround and the platform move.

Change in isometric muscle strength from baseline to mid and post-training

Time frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12)

Isometric muscle strength of bilateral hip, knee and ankle muscles is assessed using the Biodex dynamometer machine.

Change in muscle spasticity from baseline to mid and post-training

Time frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12)

Stroke-related muscle spasticity is assessed via Modified Ashworth Scale, which is a universal scale used to test spasticity. The scale is graded ranging from points 0-4 with 0 indicating no increase in muscle tone and 4 indicating that affected part is rigid in flexion and extension

Change in the Chedoke McMaster impairment from baseline to mid and post-training

Time frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12)

The Chedoke Mcmaster Assessment Scale (CMSA) (Leg and Foot Subscale). The CMSA Leg and Foot subscale, are 7-point scale each, which assess the severity of motor impairment based on Brunnstorm Stages of Motor recovery. A score of ≥4/7 is considered as low impairment in individuals with stroke.

Change in the Fugl-Meyer lower extremity scale from baseline to mid and post-training

Time frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12)

The Fugl-Meyer Assessment is a stroke-specific, performance-based index that assesses sensorimotor function, joint positioning and functioning. Total scoring is of 86 points with higher points indicating higher function.

Change in the Modified Rankin scale from baseline to mid and post-training

Time frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12)

The modified Rankin scale is 7-point measure of global disability used to assess functional disability after stroke. A score of 0 is considered as no disability whereas a score of 5 is considered as severe disability requiring constant medical care and a score of 6 indicating death.

Change in peripheral sensation from baseline to mid and post-training

Time frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12)

Peripheral sensations will be assessed using the Semmes-Weinstein Monofilament testing. Inability to perceive the 5.07/10g filament indicates loss of lower limb protective sensations.

Change in physical activity from baseline to mid and post-training

Time frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12)

Physical activity is assessed using the Physical Activity Scale for the Elderly (PASE). PASE scale is a brief 5-minute survey that is designed to assess physical activity in the last 7 days. The PASE assesses different types of activities, exercise, housework, yard work, recreational activities and caring for others. The PASE scale grading ranges from a a score of 0-793. Higher score indicates greater physical activity.

Change in balance confidence from baseline to mid and post-training

Time frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12)

Participant's balance confidence is assessed using: The Activities-specific Balance Confidence (ABC) Scale. The ABC is a 16-point scale that assesses participant perceived balance confidence during daily living activities ranging from walking around the house to walking outside on icy sidewalks. Each of the 16-points can be graded in terms of percentage with 0 indicating no confidence and 100 indicating complete confidence of not losing balance or becoming unsteady while performing the activity. Higher score indicates higher balance confidence.

Change in community participation from baseline to mid and post-training

Time frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12)

This is assessed by community integration questionnaire that assesses an individual's community integration using three domains: 1) home and 2) social integration and 3) productive activity. Higher score indicates better community participation.

Change in overall health status from baseline to mid and post-training

Time frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12)

The Short Form 36 Health Survey will be used for assessment of overall health. The SF-36 has 8-sections scores ranging from 0-100. The 8-sections include: 1) vitality 2) physical functioning 3) Bodily pain 4) General Health perceptions 5) Physical role functioning 6) Emotional role functioning 7) Social role functioning and 8) Mental Health. Higher score indicates better health status.

Change in overground gait speed from baseline to mid and post-training

Time frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12)

Overground gait speed is assessed using the 10-Meter walk test. Participants will walk for 10-meter with and without assistive device at their comfortable walking speed

Change in global cognition from baseline to mid and post-training

Time frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12)

The Montreal Cognitive assessment scale examines different domains of cognitive function like memory, attention, orientation and language and are scored ranging from 0-30 points. Higher score indicates great cognitive function. \< 19 out of 30 indicates cognitive impairment, 19-25 indicates mild cognitive impairment and above 25 indicates intact cognition.

Change in general cognition from baseline to mid and post-training

Time frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12)

Assessed using the Mini-Mental Assessment Scale (MMSE). The MMSE is a 30-point scale that tests general cognition required to perform everyday living activities. More points indicate higher cognition. A score over 26 indicates higher cognition

Change in laboratory induced falls from baseline to mid and post-training

Time frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12)

Perturbation is induced successfully and safely to reproduce inadvertent falls in a protective laboratory environment. Falls will be measured by amount of force recorded on the load cell attached to the ceiling mounted safety harness system donned by the participant. Instability of the body's COM and poor limb support prior to touchdown of the recovery step account for 90\~100% of subsequent falls (occurring \~500ms later) during treadmill-induced stance slip.

Change in center of mass stability from baseline to mid and post-training

Time frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12)

Stability is defined by both the position of a person's center-of-mass (COM) with respect to his or her base-of-support (BOS) and it's velocity. This will be assessed during treadmill-induced stance slips.

Change in limb support from baseline to mid and post-training

Time frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12)

The inability to provide timely limb support due to insufficient amount of upward impulse generated from the ground reactive force can cause limb collapse, as characterized by the quotient of amount and rate of hip descent (Vhip/Zhip) measured from hip height and lead to an eventual fall.

Change in fatigue from baseline to mid and post-training

Time frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12)

Fatigue is assessed using the Fatigue severity scale is a 9-point scale that includes statements regarding an individual's fatigue. The individual grades each statement on a scale of 0-7 with 0 indicating completely disagree and 7 indicating completely agree. Higher score indicates higher fatigue levels with total possible scoring of 63.

Change in falls efficacy from baseline to mid and post-training

Time frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12)

Falls efficacy is assessed using The Falls Efficacy Scale consisting of 10 activities of dialy living. For each of the activities, the participant has to score on a scale of 1 to 10, 1 being very confident and 10 being not confident at all, how confident is the participant that they can do the activity without falling? Lower score indicates higher confidence. A total score of greater than 70 indicates that the person has a fear of falling.

Change in maximum loading threshold from baseline to mid and post-training

Time frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12)

The spring-scale test is used to assess the maximum loading threshold for reactive balance. Participant will undergo balance testing in standing where the researcher will deliver waist-pull perturbations in anterior and posterior direction. The maximum loading threshold is the weight at which the participant can maintain their balance without stepping.

Change in maximum stepping threshold from baseline to mid and post-training

Time frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12)

The spring-scale test is used to assess the maximum stepping threshold for reactive balance. Participant will undergo balance testing in standing where the researcher will deliver waist-pull perturbations in anterior and posterior direction. The maximum stepping threshold is the weight at which participant takes a step even after resisting the waist-pull perturbation.

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