NCT05946096

Brief Summary

The purpose of this study was to determine the effect of dynamic surface exercise treatment on trunk control and gross motor abilities in children with spastic diplegic cerebral palsy.

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
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

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

November 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 14, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

July 14, 2023

Status Verified

July 1, 2023

Enrollment Period

1 year

First QC Date

April 9, 2023

Last Update Submit

July 6, 2023

Conditions

Keywords

trunk controldynamic surface exercise therapygross motor

Outcome Measures

Primary Outcomes (2)

  • Gross motor function measure- 88

    The Gross Motor Function Measure (GMFM 88) is used to evaluate change that occurs over time in the gross motor function of children with cerebral palsy. It explores five areas of motor ability, which are known as dimensions: A) Lying and rolling B) Sitting C) Crawling and kneeling D) Standing E) Walking, running and jumping

    change in baseline scores and 8th week scores

  • trunk control measurement scale

    The Trunk Control Measurement Scale is a clinical tool to measure trunk control in children with cerebral palsy. total score is 58 . low score means severely impaired trunk control and a high score shows better trunk control

    change in baseline scores and 8th week scores

Study Arms (2)

dynamic surface exercise training group

EXPERIMENTAL

This group includes 19 subjects all of which are children with spastic diplegic cerebral palsy of GMFCS levels 3 and 4. This group received a set of exercises on various dynamic surfaces along with routine physical therapy. This group underwent a 60-minutes vigorous exercise program four days a week for two months

Other: Dynamic surface exercise training

conventional physical therapy group

ACTIVE COMPARATOR

This group includes 19 subjects all of which are children with spastic diplegic cerebral palsy of GMFCS levels 3 and 4. This group received only conventional physical therapy which is based upon principles of NDT. This group underwent a 60-minutes vigorous exercise program four days a week for two months.

Other: conventional physical therapy

Interventions

Dynamic surface exercise training involves a set of exercises that are performed on various dynamic surfaces like gym ball and vestibular swing. All these exercise provide optimal arousal as they provide proprioceptive and vestibular stimulus. This group received a set of exercises on various dynamic surfaces.These exercises were implemented for 60 minutes for four days a week for two months.And it was observed how these exercises impacted gross motor function and trunk control of children with diplegic cerebral palsy of GMFCS level 3 and 4

dynamic surface exercise training group

conventional physical therapy based on NDT involves a set of exercises that mostly include positioning exercises such as quadruped, side sitting, reaching sideways and overhead in sitting and catch and throw activities.

conventional physical therapy group

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diplegic children having Cerebral Palsy
  • Children of age 5 - 12 years
  • Children of GMFCS- E \&R level III and IV
  • Children who can follow verbal commands

You may not qualify if:

  • Children with epileptic fits
  • Children presenting with lower limb muscular contractures
  • Children with scoliosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Lahore

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Ayesha Hameed, DPT

    University of Lahore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
the outcome assessor was masked and had no idea about which participants were assigned to which group
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 38 children with CP were randomly assigned to 2 groups. 1 group was interventional group and second group was control group. Both the groups were provided with therapy ( interventional group was provided with conventional therapy and intervention. control group was provided with conventional therapy only) and results were analyzed based on performance of both groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

April 9, 2023

First Posted

July 14, 2023

Study Start

November 1, 2022

Primary Completion

November 1, 2023

Study Completion

December 1, 2023

Last Updated

July 14, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations