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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-29

Study Completion Date

2026-01-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Child Development Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Participants will get separate treatment protocols and possible efforts will be put to mask the both group about the treatment.

Study Groups

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Group A

Experimental group

Group Type ACTIVE_COMPARATOR

CIMT with robotic glove

Intervention Type 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 B

Control group

Group Type ACTIVE_COMPARATOR

CIMT with standard rehabilitation

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No