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Effect of a game-based exercise training to improve arm function in people with paralysis on one side of the body

Effectiveness of an intensive, functional, gamified Rehabilitation program on upper limb motor function in people with stroke: A randomized clinical trial (EnteRtain Trial) - EnteRtain Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/09/027651
Enrollment
120
Registered
2020-09-08
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Health Condition 1: I60-I69- Cerebrovascular diseases

Interventions

Intervention1: Intensive, functional gamified training: Participants in the experimental group will receive an intensive, functional, gamified upper limb rehabilitation using the ArmAble™. The funct
Champion cleaner, Strike the mosquito, Delicious dosa, Roll the roti, Washing the vessels, Prayer (Indian Style), Door opening and closing, Ironing cloths, Pressing the switch, Counting the money, Han

Sponsors

BeAble Health Pvt Ltd IIT Hyderabad Telangana India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: (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.

Exclusion criteria

Exclusion criteria: (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

Design outcomes

Primary

MeasureTime frame
Fugl-Meyer assessment- Upper Extremity Scale (FMA-UE) Action Research Arm Test (ARAT)Timepoint: Pre-intervention (T0) Post-intervention at 2 weeks (T1) Follow up assessment at 6 weeks (T2)

Secondary

MeasureTime frame
Motricity Index (MI)-arm componentTimepoint: Pre-intervention (T0) Post-intervention at 2 weeks (T1) Follow up assessment at 6 weeks (T2);Kinematic analysisTimepoint: Pre-intervention (T0) Post-intervention at 2 weeks (T1) Follow up assessment at 6 weeks (T2);Visual analog fatigue scale (VAFS)Timepoint: Pre-intervention (T0) Post-intervention at 2 weeks (T1) Follow up assessment at 6 weeks (T2);modified Rankin Handicap Scale (mRS)Timepoint: Pre-intervention (T0) Post-intervention at 2 weeks (T1) Follow up assessment at 6 weeks (T2);Stroke impact scale (SIS) version 3.0Timepoint: Pre-intervention (T0) Post-intervention at 2 weeks (T1) Follow up assessment at 6 weeks (T2);Game user experience satisfaction scale (GUESS)Timepoint: Post-intervention at 2 weeks (T1)

Countries

India

Contacts

Public ContactDr Senthil Kumaran D

Manipal College of Health Professions

senthil.kumaran@manipal.edu9986910303

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 23, 2026