Effect of Using Adaptive Seating Equipment on Hand Function (hemiparesis)

November 26, 2020 updated by: Mai Elsayed Abbass, Cairo University

Effect of Using Adaptive Seating Equipment on Grasping and Visual Motor Integration in Children With Hemiparetic Cerebral Palsy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Faculty of physical therapy, Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adaptive seating equipment group
Study group who received the same selected program for hand function on adaptive swiss ball seating
Other: 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):

  1. Building towers and shapes with different textures weights and bright colors.
  2. Inserting different shapes in the correct hole.
  3. Dropping pellets.
  4. Stringing beads.
  5. Copying square and triangle.
  6. Opening the bottle and close it.
  7. Folding and Crumpling paper.
  8. Cutting paper by scissors.
  9. Tracing line and connecting dots.
  10. Reaching above the level of shoulder.
  11. Reaching across the midline.
  12. Squeezing water out of a sponge.
  13. Buttoning and unbuttoning button.
  14. Playing clapping games.
  15. Turning pages in a book.
  16. Lacing string.
  17. Picking up a small piece of food and bringing it into the palm.
  18. Moving a penny from the palm to the fingers.
  19. Removing socks.
  20. Brush the teeth.
Other Names:
  • Occupational therapy program for upper limb while the child sitting on adaptive seating equipment ( swiss ball)
Active Comparator: Traditional seat group
Control group who received a specially selected physical therapy program for hand function on a standard chair seating.
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):

  1. Building towers and shapes with different textures weights and bright colors.
  2. Inserting different shapes in the correct hole.
  3. Dropping pellets.
  4. Stringing beads.
  5. Copying square and triangle.
  6. Opening the bottle and close it.
  7. Folding and Crumpling paper.
  8. Cutting paper by scissors.
  9. Tracing line and connecting dots.
  10. Reaching above the level of shoulder.
  11. Reaching across the midline.
  12. Squeezing water out of a sponge.
  13. Buttoning and unbuttoning button.
  14. Playing clapping games.
  15. Turning pages in a book.
  16. Lacing string.
  17. Picking up a small piece of food and bringing it into the palm.
  18. Moving a penny from the palm to the fingers.
  19. Removing socks.
  20. Brush the teeth.
Other Names:
  • Occupational therapy program for upper limb while the child sitting on chair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change is being assessed in grasping score
Time Frame: Change from Baseline grasping score assessed at 3 months
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
change is being assessed in visual motor integration score
Time Frame: Change from Baseline visual motor integration score assessed at 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Mai Abbass, Ph.D., Cairo University
  • Principal Investigator: Ahmed Mahrous, Msc, Cairo University
  • Study Chair: Elham Salem, Ph.D., Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2018

Primary Completion (Actual)

August 15, 2018

Study Completion (Actual)

August 30, 2018

Study Registration Dates

First Submitted

November 16, 2020

First Submitted That Met QC Criteria

November 26, 2020

First Posted (Actual)

December 3, 2020

Study Record Updates

Last Update Posted (Actual)

December 3, 2020

Last Update Submitted That Met QC Criteria

November 26, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC\012\001765

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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