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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05810779
Other study ID # REC/RCR&AHS/22/0742
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 15, 2022
Est. completion date April 5, 2023

Study information

Verified date March 2023
Source Riphah International University
Contact Arnab Altaf, Mphill
Phone 03064585776
Email arnab.altaf@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to describe the comparative effects of dynamic surface training and trunk targeted training in order to ensure which method is best in improving gross motor function , balance and trunk control in children with spastic cerebral palsy . this will be randomized control study which includes participants with age 5 to 10 years


Description:

Cerebral palsy (CP) is a well-documented nonprogressive neurodevelopmental condition commencing in early childhood and persisting throughout life. The neuromuscular deficits observed in children with CP include abnormal muscle tone that affects posture, movement, alteration of balance and motor coordination, decrease in strength, and loss of selective motor control, leading to functional limitation. Neurodevelopmental principles state that the control of movement proceeds from the proximal to the distal part of the body. The trunk being the central key point of the body, proximal trunk control is a prerequisite for distal limb movement control, balance, and functional mobility. Using dynamic surface for exercise provides proprioceptive and vestibular feedback about the position of their body segments in space with adaptive motor control response to stimuli. Standard physiotherapy based on motor-learning principle is task-specific training, which involves practice of functional movements in activities of daily living. This study aims to describe the comparative effects of dynamic surface training and trunk targeted training in order to ensure which method is best in improving gross motor function , balance and trunk control in children with spastic cerebral palsy . this will be randomized control study which includes participants with age 5 to 10 years. Data will be taken from shahida islam teaching hospital Lodhran after taking consent, techniques will be applied and data will be recorded. Assessment will be made by using pedriatics balance scale , gross motor function measure (GMFM 66) and trunk control measurement scale (TCMS) for determining balance and gross motor function and trunk stability . The collective data will be analyzed in Statistical Package for Social Sciences (SPSS) 27.0


Recruitment information / eligibility

Status Recruiting
Enrollment 16
Est. completion date April 5, 2023
Est. primary completion date April 5, 2023
Accepts healthy volunteers No
Gender All
Age group 5 Years to 10 Years
Eligibility Inclusion Criteria: Children who can follow the therapist instructions - Children who have not had any procedure and surgery within the past six months - Both genders male and female - Age 5 to 10 years - Spastic cerebral palsy Exclusion Criteria: - Children with innate musculoskeletal diseases, developing Central nervous system diseases and history of orthopedic surgery - Children with genetic disorders and other severe diseases other than cerebral palsy - Children who had Botulinum Toxin A (BoNT-A) injection during the last 6 months or had seizures during the last one year were excluded from the study - Children with visual impairement - Children with hearing Impairemen

Study Design


Intervention

Other:
dynamic surface exercise
Optimal arousal Physio ball Make the child bounce, active/passive on the Swiss ball, slow/fast 5 times 5 sets Combined frontal and transverse plane movements Physio ball/ bolster High sitting: one hand weight bearing followed by trunk rotation to reach the toy on opposite side 5-7 each side 1 set Combined frontal and transverse plane movements Platform swing Reaching the toy with both the hands kept overhead and 45°-60° diagonal to the mid line 5-7 times each side 1 set
trunk targeted training
trunk training group (TTG) consist of exercises and activities focusing on the activation of the trunk muscles, pelvic control and proximal stabilization and these were combined with the trunk and gluteal muscle strengthening exercises. The trunk elongation activities, the facilitation of spinal extension, weight shifting and weight-bearing activities The children in the TTG received 45-75-minute of physiotherapy twice a week for 8 weeks

Locations

Country Name City State
Pakistan Shahida Islam Teaching Hospital Lodhran Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary pedriatic balance scale Pediatric balance scale is an outcome measurement tool used to assess functional balance skills in children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points 2 months
Primary gross motor function measure 88 GMFM-88 The Gross Motor Function Measure (GMFM) is an observational clinical tool designed to evaluate change in gross motor function in children with cerebral palsy. There are two versions of the GMFM - the original 88-item measure (GMFM-88) and the more recent 66-item GMFM (GMFM-66). The scoring system of the GMFM is a four-point scale that consists of 66 items divided into five dimensions of gross motor function:(a) lying and rolling, (b) sitting, (c) crawling and kneeling, (d) standing, and (e) walking, running and jumping 2 months
Primary Trunk control measurement scale Trunk Control Measurement Scale is the clinical tool to measure trunk control in children with cerebral palsy. Control of muscles is necessary to maintain stability around the trunk. 2 months
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