Skip to content

Repeated Manual Hand function Training Versus Hand function Training with Robotics in Persons with Stroke

Robot-Assisted Training Versus Enhanced Upper Limb training in Upper Limb Recovery following Stroke: A Randomized Clinical Trial - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/090342
Enrollment
64
Registered
2025-07-07
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: G938- Other specified disorders of brain

Interventions

Intervention1: Group I [(RAT Group)]: Participants will receive robotic-assisted training (RAT) with for 1 hour (with Robotic Machine Armeo Spring ) for five days per week, for a total of three weeks

Sponsors

All India Institute of Medical Sciences (AIIMS), Bhubaneswar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Stroke occurred within six months 2. 1st episode of stroke 3. Age between 35 to 75 years, hemodynamically stable. 4. Mild or no cognitive Deficit [Mini Mental Status Examination (MMSE) score more than 21 points) 5. Presence of minimal voluntary active shoulder (abduction and flexion) and elbow (flexion) (at least 10-20 degree active ROM at shoulder abduction and flexion and elbow movements (10-20 degree active flexion) 6. Presence of spasticity in the elbow flexors of grade one plus (1+) or more in the Modified Ashworth scale (MAS)

Exclusion criteria

Exclusion criteria: 1. Recurrent strokes 2. Presence of neuropathic pain in the affected upper limb 3. Presence of contractures of the affected wrist and fingers 4. Severe spasticity of the affected limb (MAS more than 3) 5. Cognitive dysfunction (Mini Mental Status Examination (MMSE) score less than 21 points) 6. Hemodynamically unstable patients 7. Presence of previous neurological disorder (due to any etiology)

Design outcomes

Primary

MeasureTime frame
Motor recovery: Motor recovery will be assessed with Fugl-Meyer Assessment scale for upper extremity (FMA-UE). The FMA-UE is a widely used scale to assess UE motor impairment. The maximum possible score on the FMA-UE is 66, with higher scores indicating better motor function.Timepoint: Assessments will be done at the baseline visit (V0), then at follow up visits V1, V2, and V3. (V1: 6-7 weeks follow-up, V2: 3 months follow-up, V3: 6 months follow-up).

Secondary

MeasureTime frame
Upper Limb Function: Upper limb (UL) function will be assessed with hand-function (HF) domain score of Stroke Impact Scale (SIS) and The Wolf Motor Function Test (WMFT).Timepoint: Assessments will be done at the baseline visit (V0), then at follow up visits V1, V2, and V3. (V1: 6-7 weeks follow-up, V2: 3 months follow-up, V3: 6 months follow-up).;Quality of life (QoL): QOL will be assessed with SIS scale.Timepoint: Assessments will be done at the baseline visit (V0), then at follow up visits V1, V2, and V3. (V1: 6-7 weeks follow-up, V2: 3 months follow-up, V3: 6 months follow-up).;Spasticity of UL: UL Spasticity will be assessed with modified Ashworth Scale (MAS) at elbow and wrist.Timepoint: Assessments will be done at the baseline visit (V0), then at follow up visits V1, V2, and V3. (V1: 6-7 weeks follow-up, V2: 3 months follow-up, V3: 6 months follow-up).

Countries

India

Contacts

Public ContactDr Apurba Barman

AIIMS, Bhubaneswar, Odisha

apurvaa23@gmail.com9438884211

Outcome results

None listed

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