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

Riphah International University

Status: Enrolling

Conditions: Child Development Disorder

Treatments: Other: CIMT with robotic glove; Other: CIMT with standard rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT07248735

REC/RCR&AHS/AFTAB ANSAR LODHI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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34 participants in 2 patient groups

Group A

Active Comparator group

Description:

Experimental group

Treatment:

Other: CIMT with robotic glove

Group B

Active Comparator group

Description:

Control group

Treatment:

Other: CIMT with standard rehabilitation