Effect of a game-based exercise training to improve arm function in people with paralysis on one side of the body
- Conditions
- Cerebrovascular diseases,
- Registration Number
- CTRI/2020/09/027651
- Lead Sponsor
- BeAble Health Pvt Ltd IIT Hyderabad Telangana India
- Brief Summary
Stroke lead to a wide range of upper limb impairment, activity limitation and participation restriction. Effective way to improve upper limb function is characterized by early intensive functional repetitive training. However most of the people with stroke have insufficient movement post-stroke to perform the activities and are incapable of performing intensive functional repetitive task training, as well as repetitive nature of these practices will adversely impact on adherence. Therefore, the need of the hour in upper limb rehabilitation is an innovative intervention incorporating intensive, repetitive, functional task-oriented training that can be initiated early after stroke and is also cost effective, fun based and motivating. A new gaming device called ArmAbleâ„¢ which is a non-immersive, interactive arm rehabilitation device designed to enable and encourage upper limb function with minimal therapist assistance following stroke has been developed recently. Therapy using ArmAbleâ„¢ caters intensive, repetitive training from the very initial phase of stroke recovery and it is fun-based, motivating, challenging and provides feedback. The aim of this study is to determine the effectiveness of an intensive, functional, gamified rehabilitation program using ArmAbleâ„¢ compared to a conventional therapy program on upper limb motor function and activity in people with stroke.
In this randomized, clinical, single blinded trial, a total number of 120 participants with acute/sub-acute stroke, aged between 18 and 80 years, of either gender will be included. An independent centralized stratified block randomization will be done and participants will be allocated to either experimental or comparator group. Randomization sequence will be generated by one of the investigators (SK) using a computer-generated random number table and computed in 20 permuted blocks of six participants each. Allocation concealment will be done by Sequentially Numbered Opaque Sealed Envelopes (SNOSE). Outcome assessors will be blinded to the group allocation. Stratification will be done based on age (<45 vs.>45 years), and severity of stroke (NIHSS score 5-14 (mild to moderately severe)/15-24 (severe)/>25 (very severe).
Patients in the experimental group will receive intensive, functional, gamified upper limb rehabilitation provided using Arm Ableâ„¢ for a minimum of 45 min to 1 hour along with conventional therapy. Participants in the control group will receive intensive, repetitive task-oriented movements of the affected upper limb (for a minimum of 45 min to 1 hour) and conventional therapy (45 min to 1 hour). Participants in both groups will receive 12 sessions of therapy in 2 weeks. After two weeks, participants in the both the groups will be advised to continue a home-based, functional upper limb rehabilitation program for a minimum of 30 min per day for six days a week for a period of four weeks.
*Primary outcome measures:* upper limb function (Fugl Meyer assessment for upper extremity) and activity (action research arm test) in people with stroke; *secondary outcome measures:*upper limb muscle strength (motricity index), movement quality of upper extremity reach in terms of distance and speed (movement performance analysis), fatigue (visual analog fatigue scale), activities of daily function (modified Rankin Scale), quality of life (stroke impact scale Version 3.0), and video game satisfaction (game user experience satisfaction scale). Measurements will be recorded at baseline, and following intervention at the end of 2nd and 6th week.
If found effective, functional gamifiedrehabilitation provided through ArmAbleâ„¢ can be used from the acute andsub-acute stages of stroke to make the therapy more intensive, repetitive,motivating and fun based.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 120
(1)diagnosed with unilateral stroke confirmed clinically and/or radiologically by a physician; (2) heamo-dynamically stable; (3) with a stroke severity score > 6 on NIHSS; (4)having a Brunnstorm voluntary control grade between 1-5 in the affected upper limb; (5) with a modified Ashworth scale score less than or equal to 3 in the affected upper limb;(6) having a Montreal Cognitive Assessment (MoCA) score more than or equal to 26 points; and (7) having the ability to sit with or without support.
(1) global or receptive aphasia; (2) major medical problems or co-morbidities that preclude their participation in the study (such as shoulder pain in the paretic limb, shoulder subluxation/dislocation, severe arthritis, or previous surgery with functional limitation); (3) complex regional pain syndrome; (4) functional vision and/or hearing loss limiting computer use; and (5) vestibular disorders.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fugl-Meyer assessment- Upper Extremity Scale (FMA-UE) Pre-intervention (T0) | Post-intervention at 2 weeks (T1) | Follow up assessment at 6 weeks (T2) Action Research Arm Test (ARAT) Pre-intervention (T0) | Post-intervention at 2 weeks (T1) | Follow up assessment at 6 weeks (T2)
- Secondary Outcome Measures
Name Time Method Kinematic analysis Pre-intervention (T0) modified Rankin Handicap Scale (mRS) Pre-intervention (T0) Motricity Index (MI)-arm component Pre-intervention (T0) Visual analog fatigue scale (VAFS) Pre-intervention (T0) Stroke impact scale (SIS) version 3.0 Pre-intervention (T0) Game user experience satisfaction scale (GUESS) Post-intervention at 2 weeks (T1)
Trial Locations
- Locations (1)
Kasturba Hospital
🇮🇳Udupi, KARNATAKA, India
Kasturba Hospital🇮🇳Udupi, KARNATAKA, IndiaSulfikar Ali APrincipal investigator8714462433abdurahimpgdi@gmail.com