Cerebral Palsy, Hemiplegic
Conditions
Keywords
cerebral palsy, hemiplegia, hand function, Robotic hand, Robotic Glove
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.
Interventions
DEVICERobotic 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.
OTHERConventional 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
Riphah International University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
7 Years to 15 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Jebsen-Taylor Hand Function Test | 8 Weeks | Jebsen-Taylor Hand Function Test (JTHFT) will objectively quantify functional capacity of hand. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ABILHAND-Kids | 8 Weeks | ABILHAND-Kids for perceived manual ability in daily activities (Subjective assessment). |
| Box and Block Test | 8 Weeks | Box and Block Test \[BBT\] for unilateral gross manual dexterity |
| Nine-Hole Peg Test (NHPT) | 8 weeks | Nine-Hole Peg Test (NHPT) fine finger dexterity (time to place and remove pegs) |
| o'connor test | 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. |
Countries
Pakistan
Contacts
CONTACTQamar Mehmood, Ph.D.
PRINCIPAL_INVESTIGATORQamar Mehmood, Ph.D.
Riphah International University
Outcome results
None listed