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Not yet recruiting NCT07571668

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

No phase Interventional Cerebral Palsy, Hemiplegic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Robotic Hand Therapy, Conventional physical Therapy.
Who it may be relevant to
Registry conditions: Cerebral Palsy, Hemiplegic. Basic parameters: 7 years — 15 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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 tol
  • 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 treat

Primary outcome measures

  • Jebsen-Taylor Hand Function Test [Time frame: 8 Weeks]
Secondary outcome measures (4)
  • ABILHAND-Kids [Time frame: 8 Weeks]
  • Box and Block Test [Time frame: 8 Weeks]
  • Nine-Hole Peg Test (NHPT) [Time frame: 8 weeks]
  • o'connor test [Time frame: 8 Weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • Riphah International University — Islamabad

Identifiers

NCT: NCT07571668 · RCRAHS-ISB/REC/PhD/011110

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗