Robot-assisted Versus Conventional Physical Therapy for Hand in Sub-acute Stroke

NCT07615569 | Recruiting DMC

• 1 other identifier: UOL/IREB/25/15/03/50
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aims to compare the effectiveness of robotic-assisted physiotherapy and conventional physiotherapy in improving hand function among patients with sub-acute stroke. Stroke often results in weakness, reduced hand strength, impaired dexterity, and difficulty performing daily activities due to upper-limb motor dysfunction. Early rehabilitation targeting hand recovery is essential to improve independence and quality of life. A total of 30 participants with sub-acute post-stroke spastic hemiplegia will be recruited from the University of Lahore Hospital and randomly assigned into two groups. The intervention group will receive robotic-assisted physiotherapy focused on repetitive, task-specific wrist and finger extension training using a robotic hand/wrist device, while the control group will receive conventional therapist-led upper-limb rehabilitation exercises. Both groups will undergo treatment sessions lasting 30-45 minutes, five days per week for four weeks. Outcome measures will include hand muscle strength assessed using a hand-held dynamometer, hand dexterity evaluated through the Action Research Arm Test (ARAT), and functional improvement measured using the Fugl-Meyer Assessment for Upper Extremity (FMA-UE). Additional measures such as spasticity, activities of daily living, and quality of life will also be recorded. Assessments will be conducted at baseline, during treatment, and after completion of the intervention period by a blinded assessor. The study is expected to determine whether robotic-assisted physiotherapy provides greater improvements in hand strength, dexterity, and upper-limb functional recovery compared to conventional physiotherapy in individuals recovering from stroke. Findings from this research may contribute to evidence-based rehabilitation strategies for improving upper-limb outcomes after stroke.

Conditions

Stroke; Spastic Hemiplegia; Upper Limb Motor Impairment

Keywords

Stroke; Robotic-assisted physiotherapy; Conventional physiotherapy; Hand rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in Upper Limb Motor Function Using Fugl-Meyer Assessment for Upper Extremity (FMA-UE)

  The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) will be used to evaluate motor recovery and functional improvement of the affected upper limb in participants with sub-acute stroke. The assessment includes evaluation of reflexes, movement synergy, wrist control, hand function, and coordination. Higher scores indicate better upper-limb motor performance and recovery.

  Baseline and after 4 weeks of intervention

Study Arms (2)

group A Robotic-Assisted Physiotherapy Group

EXPERIMENTAL

Participants in this group will receive robotic-assisted physiotherapy focused on wrist and finger extension training using a robotic hand/wrist rehabilitation device. Treatment will include repetitive task-specific movements, active-assist and active-resist exercises, visual feedback tasks, and functional grasp-release training. Sessions will be conducted for 30-45 minutes per session, 5 days per week for 4 weeks under therapist supervision.

Device: Robotic-Assisted Hand Rehabilitation Therapy

group B Conventional Physiotherapy Group

ACTIVE COMPARATOR

Participants in this group will receive conventional therapist-led upper-limb rehabilitation consisting of active-assisted and active range-of-motion exercises, strengthening exercises for wrist and finger extensors, task-oriented functional training, neuromuscular facilitation, mirror therapy, and activities of daily living training. Sessions will be conducted for 30-45 minutes per session, 5 days per week for 4 weeks.

Procedure: Conventional Physiotherapy

Interventions

Conventional Physiotherapy PROCEDURE

Participants will receive conventional physiotherapy focused on upper-limb rehabilitation after stroke. The treatment program will include active-assisted and active range-of-motion exercises, strengthening exercises for wrist and finger extensors, task-specific functional training, neuromuscular facilitation techniques, mirror therapy, and activities of daily living practice. Exercise intensity and task difficulty will be progressively increased according to patient ability and motor recovery. Sessions will last 30-45 minutes, 5 days per week for 4 weeks under physiotherapist supervision.

group B Conventional Physiotherapy Group

Robotic-Assisted Hand Rehabilitation Therapy DEVICE

Participants will receive robotic-assisted hand rehabilitation using a robotic hand/wrist training device designed to improve wrist and finger extension, hand coordination, and functional upper-limb recovery after stroke. The intervention will include repetitive task-specific movements, active-assist and active-resist training, grasp-release exercises, visual feedback activities, and functional motor practice supervised by a physiotherapist. Treatment intensity and robotic assistance will be progressively adjusted according to patient performance and recovery level. Sessions will last 30-45 minutes, 5 days per week for 4 weeks.

group A Robotic-Assisted Physiotherapy Group

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Both male and female adults aged 30-50 years diagnosed with post-stroke spastic hemiplegia confirmed by a neurologist.
• Stroke duration 2 weeks to 6 months (sub acute stage) with medically stable condition.
• Presence of mild to moderate upper-limb spasticity using screening test(Modified Ashworth Scale score 1-3).
• Ability to comprehend and follow simple verbal instructions using screening test (MMSE ≥ 24).

You may not qualify if:

• No history of upper-limb orthopedic surgery or botulinum toxin injections in the last 6 months.
• History of recurrent or uncontrolled seizure disorders, progressive neurological diseases, or unstable cardiovascular conditions.
• Participation in any intensive upper-limb rehabilitation program (CIMT, bimanual training, task-specific training, robotic therapy, FES therapy) within the past 6 months.
• Comorbid conditions affecting upper-limb function (fractures, severe arthritis, peripheral nerve injuries).

Sponsors & Collaborators

• Montiha Azeem: lead

Study Sites (1)

University of Lahore Teaching Hospital, Lahore

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

MeSH Terms

Conditions

Stroke; Hemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Muhammad Uzair, MSPTN

  The University of Lahore, Lahore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Uzair, MSPTN

CONTACT

03001850678; druzairmuhammad@gmail.com

Montiha Azeem, MSPTN

CONTACT

03479717317; muntahaazeem9@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: May 29, 2026
• Study Start: May 22, 2026
• Primary Completion (Estimated): June 22, 2026
• Study Completion (Estimated): June 23, 2026
• Last Updated: June 3, 2026

Record last verified: 2026-05

Locations

PA (1)