Effects of UP-CAT With and Without Visual Feedback in Children With CP

NCT ID: NCT06198179

Last Updated: 2024-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2024-02-05

Brief Summary

Cerebral palsy (CP) is the most common neurological disorder of movement and/or posture and of motor function, which are due to a non-progressive interference or abnormality of the developing brain. In hemiplegic cerebral palsy (HCP), one side of the body is involved with the upper extremity more affected than the lower. HCP is treated by addressing the underlying cause and by various form of therapy to recover motor function. Motor function in hemi paretic limb particularly fine motor skill may be improved by upper limb children action-observation therapy (UP-CAT).

Detailed Description

This will be randomized controlled trial. Non-probability purposive sampling technique will be used for recruiting samples for study. Children will be assessed by House Functional Classification System for hemiplegia to include in the study. Computerized randomization will be used to locate subjects in two groups, and 28 hemiplegic cerebral palsy children will be divided into 2 groups; experimental and control groups. In experimental group hemiplegic cerebral palsy children will perform upper limb exercises with visual feedback for 5 times a week, 15 sets of daily life upper limb activities, each action will be observed for 2 minutes and executed for 2 minutes. In control group hemiplegic cerebral palsy children will perform upper limb activities for 5 times a week, 15 sets of daily life upper limb activities, each action will be observed for 2 minutes and executed for 2 minutes. Both groups will be assessed at the time of recruitment and at the end of 4 weeks. Data will be collected by Melbourne unilateral upper limb (MUUL) and ABILHAND-kids questionnaire. After collection of data, data will be analyzed by SPSS-25.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

these individuals will receive the upper limb children action-observation training (UP-CAT) with visual feedback

UP-CAT:

• Individual tasks like modelling compound,board games,cards,magnets,glass bead to do bracelets,painting and crafting (making a grass man,making musical instruments with cardboard),cooking (making juice cocktails,fruit skewers,chocolate fondue),building towers, making puzzles & water games including filling a bucket with a sponge/bottle,filling & throwing water balloons.
• To maximize the variety of the actions we included different objects (e.g.coins,bottles, stamps,modelling compound) to be grasped with different grasp types (whole hand,pinch, tripod grasp) and in different orientations of the wrist.

Visual feedback:

Mirror in front of patient will be used. After the baseline assessment,the patient in the experimental group will receive the upper limb children action-observation training with visual feedback Time of rehabilitation will be 1 hour/subject.

Group Type: EXPERIMENTAL

upper limb children action-observation training (UP-CAT) with visual feedback

Intervention Type: OTHER

upper limb children action-observation training (UP-CAT) with visual feedback: Mirror therapy as visual feedback

Control group

This will receive the upper limb children action-observation training (UP-CAT).

UP-CAT:

Following tasks will be performed by children

• Individual tasks like modelling compound,board games,cards,magnets,glass bead to do bracelets,painting and crafting (making a grass man,making musical instruments with cardboard),cooking (making juice cocktails,fruit skewers,chocolate fondue),building towers, making puzzles & water games including filling a bucket with a sponge/bottle,filling & throwing water balloons
• To maximize the variety of the actions we included different objects (e.g. coins,bottles, stamps,modelling compound) to be grasped with different grasp types (whole hand,pinch, tripod grasp) & in different orientations of the wrist.After the baseline assessment,the patient in the experimental group will receive the UL children action-observation training with visual feedback Time of rehabilitation will be 1 hour per subject.

Group Type: OTHER

upper limb children action-observation training (UPCAT)

Intervention Type: OTHER

upper limb children action-observation training (UPCAT) without visual Feedback

Interventions

upper limb children action-observation training (UPCAT)

upper limb children action-observation training (UPCAT) without visual Feedback

Intervention Type: OTHER

upper limb children action-observation training (UP-CAT) with visual feedback

upper limb children action-observation training (UP-CAT) with visual feedback: Mirror therapy as visual feedback

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Cerebral palsy children aged 5 years to 10 years at the time of recruitment.
• Both male and female
• According to Modified Ashworth scale of spasticity; score should be +1.
• Mild or moderate UL disability i.e. active use of affected UL from poor active assist use to complete spontaneous use according to House Functional Classification System grade between 4 and 8.

Exclusion Criteria

• Individuals with the other neurological deficits
• Visual impairment.
• Children with upper limb disabilities other than hemiplegic cerebral palsy.
• Children with uncontrolled epileptic seizures in last 3 years
• Non co-operative patients.
• Previous orthopedic surgery or botulinum toxin A (BoNT-A) injection in the UL within 6 months prior to the enrolment of this study.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

IQRA Muhammad Afzal, MS*

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Riphah International University

Lahore, Punjab Province, Pakistan

Countries

Pakistan

References

Sgandurra G, Cecchi F, Beani E, Mannari I, Maselli M, Falotico FP, Inguaggiato E, Perazza S, Sicola E, Feys H, Klingels K, Ferrari A, Dario P, Boyd RN, Cioni G. Tele-UPCAT: study protocol of a randomised controlled trial of a home-based Tele-monitored UPper limb Children Action observation Training for participants with unilateral cerebral palsy. BMJ Open. 2018 May 14;8(5):e017819. doi: 10.1136/bmjopen-2017-017819.

Reference Type: BACKGROUND

PMID: 29764869 (View on PubMed)

Other Identifiers

REC/RCR&AHS/23/0753

Identifier Type: -

Identifier Source: org_study_id