NCT06748235

Brief Summary

Hemiplegia is the medical term for paralysis of one side of the body This means their shoulder; arm, hand, leg and foot are all completely paralyzed.. It results in muscular wasting on the affected side, impairs gait, reduces motor abilities, and causes instability and a loss of grasping capacity. The patient\'s quality of life is impacted by hemiplegia because it impairs brain and spinal cord functions Hemiplegic cerebral palsy is the type of cerebral palsy in which there is absolutely no use of one side of the body. This means their shoulder; arm, hand, leg and foot are all completely paralyzed. Hemiplegia in infants and children is a type of Cerebral Palsy that results from damage to the part (hemisphere) of the brain that controls muscle movements. This damage may occur before, during or shortly after birth. The term hemiplegia means that the paralysis is on one vertical half of the body.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 3, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 27, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2025

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

3 months

First QC Date

November 3, 2024

Last Update Submit

December 20, 2024

Conditions

Keywords

Cerebral palsyMuscle strengthUpper extremity

Outcome Measures

Primary Outcomes (2)

  • Jebsen-Taylor Hand Function Test (JTHFT)

    The Jebsen-Taylor Hand Function Test (JTHFT) is a standardized and objective measure of fine and gross motor hand function using simulated activities of daily living (ADL). The JTHFT has seven subsets which are writing, simulated page-turning, lifting small objects, stimulated tree feeding, stacking, and lifting large, lightweight, and heavy objects. \[JTHFT finds easy applicability in clinical settings since it can be administered in a short time by using readily available materials. Several studies report that the JTHFT is a valid assessment tool for the measurement of hand dysfunctions from a variety of patient populations having high reliability were (0.84-0.94 )

    15 to 30 minutes

  • ABIL HAND

    ABILHAND-Kids Survey, which evaluates upper extremity function in children with cerebral palsy ABILHAND-Kids survey evaluates the bilateral upper extremities of children, and which has proven validity and reliability were 0.96 and 0.70 , including 21 questions for families related to the common tasks undertaken by their children in their daily living activities. The ABILHAND-Kids survey was originally developed in French as a standard means of assessment of manual ability in children with CP. This survey evaluates the most typical indicators of manual activity, in which some of the items were developed based on the ABILHAND-Kids survey, which was developed to assess manual ability in adult patients, while other items were selected from existing scales or were adapted to broaden the variability of activities

    10 - 20 minutes

Study Arms (2)

Experimental group will received Comprehensive Hand Repetitive Intensive Strength Training

EXPERIMENTAL

Physical Therapy 60 minutes per session, three sessions a week, at a total of 30 sessions per ten weeks. Comprehensive hand repetitive intensive strength training included treadmill training for the upper limb with body weight supporting the using upper limb. The posture of an arm swing was to maintain the joints of the elbows and wrist as much as possible, and the shoulder joint was allowed to be flexed by 160 degrees.

Other: Intensive Strength Training

Routine Physical Therapy

OTHER

control will received 60 minutes per a session, three sessions a week, at a total of 30 sessions per 10 weeks by creating a home program, which consisted of a total of 8 exercises that enhanced the muscular strength of the upper limb including the triceps brachii and extensor carpi radialis, and conveyed an effect of reaching the muscles out.

Other: Routine Physical Therapy

Interventions

Comprehensive Hand Repetitive Intensive Strength Training and Routine Physical Therapy 60 minutes per session, three sessions a week, at a total of 30 sessions per ten weeks. Comprehensive hand repetitive intensive strength training included treadmill training for the upper limb with body weight supporting the using upper limb. The posture of an arm swing was to maintain the joints of the elbows and wrist as much as possible, and the shoulder joint was allowed to be flexed by 160 degrees .The posture of the arm stance supported the weight using metacarpal heads, hands, and elbows, and the shoulder joints were allowed to be flexed by 90 degrees.

Experimental group will received Comprehensive Hand Repetitive Intensive Strength Training

Received 60 minutes per a session, three sessions a week, at a total of 30 sessions per 10 weeks by creating a home program, which consisted of a total of 8 exercises that enhanced the muscular strength of the upper limb including the triceps brachii and extensor carpi radialis, and conveyed an effect of reaching the muscles out. flexion and extension muscle strengthening with towel, hand grip and wrist extension muscle strengthening This exercise consisted of shoulder extension muscle, elbow flexion muscle, shoulder abduction muscle, and elbow extension muscle strengthening with a thera band, as well as hand grip, forearm with a velcro board, wrist extension muscle strengthening with sandbag and shoulder abduction-extension muscle strengthening with a thera band.

Routine Physical Therapy

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Ages 6 to 12 years will be included
  • Both genders will be included
  • GMFCS I and II
  • Children who have normal communication skills and cognitive functions will be included

You may not qualify if:

  • Children having damage to the musculoskeletal system including fracture of the upper limb and contracture will be excluded
  • Children who have undergone the administration of medicine influencing muscular strength and spasticity will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Riphah International University

Lahore, Punjab Province, Pakistan

RECRUITING

Related Publications (1)

  • Kara OK, Yardimci BN, Sahin S, Orhan C, Livanelioglu A, Soylu AR. Combined Effects of Mirror Therapy and Exercises on the Upper Extremities in Children with Unilateral Cerebral Palsy: A Randomized Controlled Trial. Dev Neurorehabil. 2020 May;23(4):253-264. doi: 10.1080/17518423.2019.1662853. Epub 2019 Sep 13.

    PMID: 31514564BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Nisha Feroz, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad Dr, PhD

CONTACT

Muhammad Asif Javed, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
participant will get separate treatment protocol and possible efforts will be put to mask the both group about the treatment
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: It will be randomized control trial in which non probability convenient sampling will be used. Two groups of 6-12 age will be formed in which participants will be randomly divided. Group A will be receive Group-Task-Oriented Training. Group B will be receive routine therapy
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2024

First Posted

December 27, 2024

Study Start

September 25, 2024

Primary Completion

December 25, 2024

Study Completion

January 10, 2025

Last Updated

December 27, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations