NCT06198179

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

December 26, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2024

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

December 26, 2023

Last Update Submit

June 11, 2024

Conditions

Keywords

Cerebral palsy (CP),RehabilitationUpper extremityActivities of daily living

Outcome Measures

Primary Outcomes (2)

  • Melbourne Assessment of Unilateral Upper Limb Function (MUUL)

    The MUUL is an evaluative tool that measures unilateral upper extremity quality of movement in children with neurological impairments aged from 5 to 15 years. MUUL is a criterion-referenced test based on 16 items scored on a 3- to 5-point ordinal scale comprising tasks that are representative of the most important components of unilateral UL function

    4 weeks

  • ABILHAND-Kids

    The ABILHAND-Kids is a short questionnaire that measures 21 mainly bimanual daily activities referred to the activity domain of the ICF. The difficulty experienced by the child to perform the required tasks is scored by a parent on a 3-point ordinal scale (impossible, difficult, and easy).

    4 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

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.

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

Control group

OTHER

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.

Other: upper limb children action-observation training (UPCAT)

Interventions

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

Control group

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

Experimental group

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Punjab Province, Pakistan

Location

Related Publications (1)

  • 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.

    PMID: 29764869BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • IQRA Muhammad Afzal, MS*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study will be randomized controlled trial (RCT) used to measure the effects of upper limb action-observation training (UP-CAT) with and without visual feedback in children with cerebral palsy. subjects with cerebral palsy meeting pre determined inclusion and exclusion criteria will be be divided into two groups using non-probability sampling techniques.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2023

First Posted

January 10, 2024

Study Start

December 1, 2023

Primary Completion

February 5, 2024

Study Completion

February 5, 2024

Last Updated

June 13, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations