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How game-based therapy can help stroke patients become more active

Effectiveness of A Game Based Rehabilitation on Sedentary Behavior and Physical Activity in Patients with Acute and Subacute Stroke A Multicenter Randomized Clinical Trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/01/079679
Enrollment
105
Registered
2025-01-28
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I633- Cerebral infarction due to thrombosis of cerebral arteries

Interventions

Intervention1: Game based rehablitation using ArmAble and conventional therapy and Home based context specific exercise training and: Game-based rehabilitation-ArmAble Rationale: Neuroplasticity, enh

Sponsors

Manipal Academy of Higher Education
Lead Sponsor
Be Able Health Pvt Ltd
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: PHASE ONE The presence of the first ischemic or hemorrhagic stroke has been clinically and radiologically confirmed by a physician. Aged eighteen years and above Medically stable (with systolic blood pressure: one hundred twenty to one hundred sixty millimeters of mercury Oxygen saturation: greater than ninety-two percent Heart rate: forty to one hundred beats per minute Temperature: less than thirty-eight point five degrees Celsius) Montreal Cognitive Assessment score greater than or equal to twenty-six points Stroke severity score greater than five and less than twenty-four on the NIH Stroke Scale (NIHSS) PHASE TWO The presence of the first ischemic or hemorrhagic stroke has been clinically and radiologically confirmed by a physician. Aged eighteen years and above Medically stable (with systolic blood pressure: one hundred twenty to one hundred sixty millimeters of mercury Oxygen saturation: greater than ninety-two percent Heart rate: forty to one hundred beats per minute Temperature: less than thirty-eight point five degrees Celsius) Patients with premorbid disability with a modified Rankin Scale score less than four Stroke severity score greater than five and less than twenty-four on the NIH Stroke Scale (NIHSS) The Brunnstrom voluntary control grade greater than or equal to one and less than or equal to six in the affected limb Modified Ashworth Scale score less than or equal to three in the affected limb Montreal Cognitive Assessment score greater than or equal to twenty-six points Ability to come to a propped-up position with or without support

Exclusion criteria

Exclusion criteria: PHASE 1 Global or receptive aphasia Severe infections and cardiopulmonary diseases Any brain-related surgical procedure Any skin problems in the area of accelerometer placement. Any other musculoskeletal conditions or significant medical problems or co-morbidities Early deterioration/Premature decline Isolation regime because of infection Physician-ordered bed rest PHASE 2 Global or receptive aphasia Severe infections and cardiopulmonary diseases (acute coronary syndrome, severe heart failure) Any brain-related surgical procedure Any skin problems in the area of accelerometer placement. Early deterioration/Premature decline Any other musculoskeletal conditions or significant medical problems or co-morbidities Isolation regime because of infection Physician-ordered bed rest

Design outcomes

Primary

MeasureTime frame
Fibion Accelerometer data Timepoint: Phase 1 Continuous monitoring will be performed from the time of recruitment until hospital discharge or up to 7 days, whichever occurs first. Phase 2 Continuous monitoring will be conducted for 3 consecutive days post-recruitment and repeated for an additional 3 consecutive days at the end of the 3-week intervention period.

Secondary

MeasureTime frame
The National Institutes of Health Stroke Scale (NIHSS) Timepoint: Phase 1 Assessments will be conducted at the time of recruitment & at hospital discharge, or on the 7th day post-recruitment, whichever occurs first. Phase 2 Assessments will be conducted at the time of recruitment & at the end of the 3-week intervention period.;Montreal Cognitive Assessment (MoCA) Timepoint: Phase 1 Assessments will be conducted at the time of recruitment & at hospital discharge or on the 7th day post-recruitment, whichever occurs first. A follow-up assessment will be performed 1 month after this time point, via a telephonic interview. Phase 2 Assessments will be conducted at the time of recruitment & at the end of the 3-week intervention period. A follow-up assessment will be performed 1 month after completion of the 3-week intervention, via a telephonic interview.;Fugl-Meyer Assessment (FMA) Timepoint: Phase 1 Assessments will be conducted at the time of recruitment & at hospital discharge, or on the 7th day post-recruitment, whichever occurs first. Phase 2 Assessments will be conducted at the time of recruitment & at the end of the 3-week intervention period.;Berg Balance Scale (BBS) Timepoint: Phase 1 Assessments will be conducted at the time of recruitment & at hospital discharge, or on the 7th day post-recruitment, whichever occurs first. Phase 2 Assessments will be conducted at the time of recruitment & at the end of the 3-week intervention period.;Modified Rankin Scale(mRS) Timepoint: Phase 1 Assessments will be conducted at the time of recruitment & at hospital discharge or on the 7th day post-recruitment, whichever occurs first. A follow-up assessment will be performed 1 month after this time point, via a telephonic interview. Phase 2 Assessments will be conducted at the time of recruitment & at the end of the 3-week intervention period. A follow-up assessment will be performed 1 month after completion of the 3-week intervention, via a telephon

Countries

India

Contacts

Public ContactDr Senthil Kumaran D

Manipal college of Health Professions, Manipal Academy of Higher education, Manipal

senthil.kumaran@manipal.edu9986910303

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026