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

NCT07248735 | Recruiting DMC

• 1 other identifier: REC/RCR&AHS/AFTAB ANSAR LODHI
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Child Development Disorder

Keywords

CIMT, Robotic Gloves, Dexterity, Hemiplegic CP

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Group A

ACTIVE COMPARATOR

Experimental group

Other: CIMT with robotic glove

Group B

ACTIVE COMPARATOR

Control group

Other: CIMT with standard rehabilitation

Interventions

CIMT with robotic glove OTHER

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.

Group A

CIMT with standard rehabilitation OTHER

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.

Group B

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Imran Amjad

Lahore, Punjab Province, 5400, Pakistan

RECRUITING

Related Publications (1)

• 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.

  PMID: 32138780 BACKGROUND

MeSH Terms

Conditions

Developmental Disabilities

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Aftab Ansar Lodhi, MS-PT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, PhD

CONTACT

9233224390125; imran.amjad@riphah.edu.pk

Muhammad Asif Javed, MS-PT

CONTACT

923224209422; a.javed@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will get separate treatment protocols and possible efforts will be put to mask the both group about the treatment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: October 29, 2025
• Primary Completion: January 25, 2026
• Study Completion: January 30, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)