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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 3, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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