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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04651283
Other study ID # P.T.REC\012\001765
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2018
Est. completion date August 30, 2018

Study information

Verified date November 2020
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Objective: The purpose of this study was to evaluate the effect of adaptive swiss ball seating as an alternative for standard chair seating on hand function in children with hemiparesis. Subjects: A total of 30 spastic hemiparetic cerebral palsied children (19 boys and 11 girls), aged 3-6 years participated in this study. They were randomly assigned into control and study groups of equal numbers each consisted of fifteen children (n=15). Methods: Peabody Developmental Motor Scales 2 (PDMS-2) was used to evaluate each child individually before and after three successive months of treatment (3 sessions per week), to assess 2 subtests (the grasping skills and visual motor integration skills) for all children of both groups. Control group who received a specially selected physical therapy program for hand function on a standard chair seating. Study group who received the same selected program for hand function on adaptive swiss ball seating.


Description:

The aim of this study was to evaluate the effect of adaptive swiss ball seating as an alternative for standard chair seating on hand function in children with hemiparesis. In this study, a total of 30 spastic hemiparetic cerebral palsied children (19 boys and 11 girls) aged 3-6 years, they were selected from general hospitals and private centers in kafr El-Sheikh government, randomly assigned to either the control group (n=15), who received a specially selected physical therapy program for hand function on standard chair seating, or the study group (n=15), who received the same selected program for hand function but on adaptive Swiss ball seating. Both groups received 3 sessions per week for 3 successive months. Peabody Developmental Motor Scales 2 (PDMS-2) was used to evaluate each child individually before and after three successive months of treatment, to assess 2 subtests (grasping skills and visual motor integration skills).


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date August 30, 2018
Est. primary completion date August 15, 2018
Accepts healthy volunteers No
Gender All
Age group 3 Years to 6 Years
Eligibility Inclusion Criteria: - Children with hemiparetic cerebral palsy. - The age of the selected children ranged from 3 to 6 years old. - Degree of spasticity ranged from 1 to 1+, according to Modified Ashworth' Scale (Bohannon and Smith, 1987) - They were able to follow instructions and understand commands included in both assessment and training procedures. - They were able to sit independent with trunk control. Exclusion Criteria: - Children exposed to orthopedic surgeries or potolinium toxins injection in the last 6 mounth before intervention. - Children with fixed upper limb deformities - Children with hearing or visual impairments.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Traditional seat group
Each child in the control group was asked to conduct or follow instructions given for him or her to conduct the following hand function tasks for three successive months of treatment, three times per week (every other day): Building towers and shapes with different textures weights and bright colors. Inserting different shapes in the correct hole. Dropping pellets. Stringing beads. Copying square and triangle. Opening the bottle and close it. Folding and Crumpling paper. Cutting paper by scissors. Tracing line and connecting dots. Reaching above the level of shoulder. Reaching across the midline. Squeezing water out of a sponge. Buttoning and unbuttoning button. Playing clapping games. Turning pages in a book. Lacing string. Picking up a small piece of food and bringing it into the palm. Moving a penny from the palm to the fingers. Removing socks. Brush the teeth.
Adaptive seating equipment group
Each child in the study group was asked to conduct or follow instructions given for him or her to conduct the following hand function tasks for three successive months of treatment, three times per week (every other day): Building towers and shapes with different textures weights and bright colors. Inserting different shapes in the correct hole. Dropping pellets. Stringing beads. Copying square and triangle. Opening the bottle and close it. Folding and Crumpling paper. Cutting paper by scissors. Tracing line and connecting dots. Reaching above the level of shoulder. Reaching across the midline. Squeezing water out of a sponge. Buttoning and unbuttoning button. Playing clapping games. Turning pages in a book. Lacing string. Picking up a small piece of food and bringing it into the palm. Moving a penny from the palm to the fingers. Removing socks. Brush the teeth.

Locations

Country Name City State
Egypt Faculty of physical therapy, Cairo university Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary change is being assessed in grasping score Assessment of grasping using Peabody Developmental Motor Scale 2 the higher score means a better outcome Change from Baseline grasping score assessed at 3 months
Primary change is being assessed in visual motor integration score Assessment of visual motor integration using Peabody Developmental Motor Scale 2 the higher score means a better outcome Change from Baseline visual motor integration score assessed at 3 months
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