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NCT Number: NCT07571668

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

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.

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Key information

Conditions

Cerebral Palsy, Hemiplegic Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Hemiplegia Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

7 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Jebsen-Taylor Hand Function Test

    Time frame: 8 Weeks

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

Secondary outcomes

  1. ABILHAND-Kids

    Time frame: 8 Weeks

    ABILHAND-Kids for perceived manual ability in daily activities (Subjective assessment).

  2. Box and Block Test

    Time frame: 8 Weeks

    Box and Block Test [BBT] for unilateral gross manual dexterity

  3. Nine-Hole Peg Test (NHPT)

    Time frame: 8 weeks

    Nine-Hole Peg Test (NHPT) fine finger dexterity (time to place and remove pegs)

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Qamar Mehmood, Ph.D.

CONTACT

[email protected]

+923335151063

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 6, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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