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

NCT07571668 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-05-06

No results posted yet for this study

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

Interventions

DEVICE

Robotic Hand Therapy

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.

OTHER

Conventional physical Therapy

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.

Sponsors & Collaborators

  • Riphah International University

    lead OTHER

Principal Investigators

  • Qamar Mehmood, Ph.D. · Riphah International University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-06-30
Completion
2027-12-31

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07571668 on ClinicalTrials.gov