Effects of Robotic Hand Therapy on Hand Function and Dexterity in Cerebral Palsy

NCT07571668 | Not Yet Recruiting DMC

• 1 other identifier: RCRAHS-ISB/REC/PhD/011110
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aims to evaluate the effects of robotic hand therapy using the Syrebo E12 soft-robotic glove compared with conventional physiotherapy on hand function and manual dexterity in children with hemiplegic cerebral palsy. Children aged 7-15 years, classified as GMFCS I-III and MACS I-III, will be recruited from multiple rehabilitation centers in Pakistan. Participants will be randomly allocated (1:1) to either robotic therapy or standard physiotherapy, receiving 45-minute sessions, three times per week for 8 weeks. The primary outcome is functional hand performance measured by the Jebsen-Taylor Hand Function Test (JTHFT). Secondary outcomes include ABILHAND-Kids, Box and Block Test, Nine-Hole Peg Test, grip strength, and qualitative feedback. Assessments will occur at baseline, week 4, week 8, and at a 6-month follow-up. A mixed-effects repeated-measures ANCOVA will be used for analysis following the intention-to-treat principle.

Conditions

Cerebral Palsy, Hemiplegic

Keywords

cerebral palsy; hemiplegia; hand function; Robotic hand; Robotic Glove

Outcome Measures

Primary Outcomes (1)

• Jebsen-Taylor Hand Function Test

  Jebsen-Taylor Hand Function Test (JTHFT) will objectively quantify functional capacity of hand.

  8 Weeks

Secondary Outcomes (4)

• ABILHAND-Kids

  8 Weeks

• Box and Block Test

  8 Weeks

• Nine-Hole Peg Test (NHPT)

  8 weeks

• o'connor test

  8 Weeks

Study Arms (2)

Robotic Hand Therapy

EXPERIMENTAL

Device: Robotic Hand Therapy

Conventional Physical Therapy

ACTIVE COMPARATOR

Other: Conventional physical Therapy

Interventions

Robotic Hand Therapy DEVICE

Participants in this group will receive robotic hand therapy using a glove-based robotic rehabilitation device that provides passive, active-assisted, and resistive training to facilitate repetitive, task-specific hand movements. Each 45-minute session will be delivered three times per week for six weeks under therapist supervision, focusing on improving grasp-release patterns, finger mobility, and functional hand use. Therapy intensity will be progressively adjusted based on performance and tolerance, and all sessions will be monitored for safety and adverse events.

Robotic Hand Therapy

Conventional physical Therapy OTHER

Participants in this group will receive conventional physical therapy based on neurodevelopmental and task-oriented principles, including stretching, strengthening, sensory re-education, and functional hand-use training. Sessions will last 45 minutes, three times per week for six weeks, delivered by a licensed physical therapist following a standardized treatment checklist. The program targets improvements in hand strength, dexterity, range of motion, and fine motor skills, with safety and treatment fidelity monitored throughout.

Conventional Physical Therapy

Eligibility Criteria

• Age: 7 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients diagnosed with Hemiplegic type of Cerebral palsy
• Age 7 to 15 years
• Ability to understand and follow simple instructions
• Gross Motor Function Classification System (GMFCS) levels I-III (ambulatory)
• Manual Ability Classification system (MACS) I to III
• Stable medical condition (no major changes in medication or therapy in the past 3 months).

You may not qualify if:

• Patients with severe cognitive dysfunction.
• Fixed contractures or deformities of the upper limb that would prevent safe use of the robotic device.
• Recent upper limb surgery, botulinum toxin injection, or casting within the past 6 months.
• Uncontrolled epilepsy or other unstable medical conditions.
• Visual or auditory impairments that would interfere with assessment or therapy.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Islamabad, Pakistan

Location

MeSH Terms

Conditions

Cerebral Palsy; Hemiplegia

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Qamar Mehmood, Ph.D.

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qamar Mehmood, Ph.D.

CONTACT

+923335151063; qamar.mehmood@riphah.edu.pk

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

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 6, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)