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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorRiphah International University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • CIMT with robotic glove

    Other intervention

    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.

  • CIMT with standard rehabilitation

    Other intervention

    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.

Treatment groups

34 Participants
are divided into 2 treatment groups
Group A: Group AActive comparator 1 intervention
Group B: Group BActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
4-8 weeks
2

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

Time frame
4-8 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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