NCT05810779

Brief 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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

September 15, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 12, 2023

Completed
Last Updated

April 12, 2023

Status Verified

March 1, 2023

Enrollment Period

7 months

First QC Date

January 4, 2023

Last Update Submit

March 31, 2023

Conditions

Keywords

BalanceCerebral palsyDynamic surface trainingGross motor function.

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

dynamic surface exercise with conventional therapy

EXPERIMENTAL

the experimental group undergo conventional physical therapy and additional dynamic surface exercise training thrice a week for 2 months dynamic surface training will include gym balls , bolster or platform swing

Other: dynamic surface exercise

trunk targeted training with conventional therapy

ACTIVE COMPARATOR

the group will receive conventional physical therapy and additional trunk targeted training thrice a week for 2 months.

Other: trunk targeted training

Interventions

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

Also known as: comparison between dynamic surface exercise and trunk targeted training
dynamic surface exercise with conventional therapy

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

Also known as: comparison between dynamic surface exercise and trunk targeted training
trunk targeted training with conventional therapy

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shahida Islam Teaching Hospital

Lodhran, Punjab Province, 59320, Pakistan

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Arnab Altaf, Mphill

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2023

First Posted

April 12, 2023

Study Start

September 15, 2022

Primary Completion

April 5, 2023

Study Completion

April 5, 2023

Last Updated

April 12, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations