Effects of CIMT With and Without Robotic Gloves in Children With Hemiplegic CP

Effects of Constraint Induced Movement Therapy With and Without Robotic Glove on Dexterity and Hand Grip Strength in Children With Hemiplegic Cerebral Palsy

This study investigates the impact of CIMT, with and without robotic gloves, on hand dexterity and grip strength in children with hemiplegic CP, aiming to enhance motor skills and promote independence in daily activities. Conducted as a randomized controlled trial at DHQ Hospital, Mandi Bahauddin, the study involves two groups of children aged 6-12 with hemiplegic CP. One group of 17 children will receive CIMT alone with standard treatment, while the other 17 will receive CIMT combined with robotic glove assistance. The robotic glove device aids in flexion, extension, and individual finger movements, providing support for both isolated and coordinated finger actions. Each therapy session will last six hours and be held three to five days a week over four to eight weeks.

Study Overview

• Status: Recruiting
• Conditions: Child Development Disorder
• Intervention / Treatment: Other: CIMT with robotic glove; Other: CIMT with standard rehabilitation

Detailed Description

Hemiplegic cerebral palsy (CP) often affects one side of the body, limiting functional abilities. Constraint-Induced Movement Therapy (CIMT) is a common intervention where the unaffected hand is restricted to encourage the use of the affected hand. Recently, the addition of robotic gloves has been proposed to improve outcomes, as they offer mechanical support and feedback to the affected hand. This study investigates the impact of CIMT, with and without robotic gloves, on hand dexterity and grip strength in children with hemiplegic CP, aiming to enhance motor skills and promote independence in daily activities. Conducted as a randomized controlled trial at DHQ Hospital, Mandi Bahauddin, the study involves two groups of children aged 6-12 with hemiplegic CP. One group of 17 children will receive CIMT alone with standard treatment, while the other 17 will receive CIMT combined with robotic glove assistance. The robotic glove device aids in flexion, extension, and individual finger movements, providing support for both isolated and coordinated finger actions. Each therapy session will last six hours and be held three to five days a week over four to eight weeks.

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: IMRAN AMJAD, PhD; Phone Number: 9233224390125; Email: imran.amjad@riphah.edu.pk
• Study Contact Backup: Name: Muhammad Asif Javed, MS-PT; Phone Number: 923224209422; Email: a.javed@riphah.edu.pk

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 5400
      • Recruiting
      • Imran Amjad
      • Contact: Muhmmad Asif Javed, MS; Phone Number: 033224209422; Email: a.javed@ripah.edu.pk
      • Contact: Aftab Ansar Lodhi, MS-PT; Phone Number: 03128575174; Email: aftabansarlodhi@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Children aged 6-12 years with Hemiplegic CP.
• Both Genders will be included.
• Fulfilling the CIMT criteria i.e. Up to 20 Degree Wrist Extension, up to 10 Degree
• Thumb Abduction and Up to 10 Degree Finger Extension.
• GMFCS level of 1 and 2.
• MAC Grade 2 and 3.
• Ability to understand and follow simple instructions.

Exclusion Criteria:

• Severe cognitive impairment or intellectual disability.
• Presence of other neurological disorders such as epilepsy.
• Children currently participating in other intensive physical therapy programs.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group B; Control group	Other: CIMT with standard rehabilitation; Controlled group receives CIMT with baseline rehabilitation. Only receives CIMT without Robotic Gloves. Additional assessments may be conducted after 3 or 6 months to measure long-term effects.
Active Comparator: Group A; Experimental group	Other: CIMT with robotic glove; The Experimental group undergoes a comprehensive rehabilitation program, combining Constraint-Induced Movement Therapy (CIMT) with robotic glove therapy. The unaffected limb is restrained by the help of Slings, Simple glove, splint or plaster. Each session lasts 6 Hours, occurring 3-5 Days a weekly, over a period of 4-8 weeks. This intensive regimen aims to enhance hand function and mobility by constraining the unaffected hand while using the robotic glove to facilitate precise finger movements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grip Strength Test	The grip strength test and pinch strength is used to assess function of the hand using dynamometer. Grip strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles. It can be used as a screening tool for the measurement of upper body strength and overall strength	4-8 weeks
Box and Block Test	The Box and Block Test (BBT) measures unilateral gross manual dexterity. It is a quick, simple and inexpensive test. The BBT is composed of a wooden box divided in two EFFECTS OF CIMT WITH AND WITHOUT ROBOTIC GLOVES IN CHILDREN WITH HEMIPLEGIC CP 11 compartments by a partition and 150 blocks. The BBT administration consists of asking the client to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds	4-8 weeks

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Aftab Ansar Lodhi, MS-PT, Riphah International University

Publications and helpful links

General Publications

• Osuagwu BAC, Timms S, Peachment R, Dowie S, Thrussell H, Cross S, Shirley R, Segura-Fragoso A, Taylor J. Home-based rehabilitation using a soft robotic hand glove device leads to improvement in hand function in people with chronic spinal cord injury:a pilot study. J Neuroeng Rehabil. 2020 Mar 5;17(1):40. doi: 10.1186/s12984-020-00660-y.

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2025
• Primary Completion (Estimated): January 25, 2026
• Study Completion (Estimated): January 30, 2026

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: CIMT, Robotic Gloves, Dexterity, Hemiplegic CP
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Developmental Disabilities
• Other Study ID Numbers: REC/RCR&AHS/AFTAB ANSAR LODHI

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