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

April 30, 2026 updated by: Riphah International University

Effects of Robotic Hand Therapy in Comparison to Conventional Therapy on Hand Function and Dexterity in Children With Hemiplegic Cerebral Palsy; a Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
      • Islamabad, Pakistan
        • Riphah International University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional Physical Therapy
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.
Experimental: Robotic Hand Therapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Jebsen-Taylor Hand Function Test
Time Frame: 8 Weeks
Jebsen-Taylor Hand Function Test (JTHFT) will objectively quantify functional capacity of hand.
8 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ABILHAND-Kids
Time Frame: 8 Weeks
ABILHAND-Kids for perceived manual ability in daily activities (Subjective assessment).
8 Weeks
Box and Block Test
Time Frame: 8 Weeks
Box and Block Test [BBT] for unilateral gross manual dexterity
8 Weeks
Nine-Hole Peg Test (NHPT)
Time Frame: 8 weeks
Nine-Hole Peg Test (NHPT) fine finger dexterity (time to place and remove pegs)
8 weeks
o'connor test
Time Frame: 8 Weeks
The O'Connor Finger Dexterity Test is a, standardized, timed, aptitude assessment designed to measure fine motor skills and rapid, precise manipulation of small objects. It is widely used in vocational testing, industrial hiring (assembly line work), and clinical rehab to evaluate finger dexterity by placing three pins into 100 holes.
8 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Qamar Mehmood, Ph.D., Riphah International University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

April 30, 2026

First Submitted That Met QC Criteria

April 30, 2026

First Posted (Actual)

May 6, 2026

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCRAHS-ISB/REC/PhD/011110

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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