NCT04651283

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2018

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2018

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 3, 2020

Completed
Last Updated

December 3, 2020

Status Verified

November 1, 2020

Enrollment Period

7 months

First QC Date

November 16, 2020

Last Update Submit

November 26, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Adaptive seating equipment group

EXPERIMENTAL

Study group who received the same selected program for hand function on adaptive swiss ball seating

Other: Adaptive seating equipment group

Traditional seat group

ACTIVE COMPARATOR

Control group who received a specially selected physical therapy program for hand function on a standard chair seating.

Other: Traditional seat group

Interventions

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.

Also known as: Occupational therapy program for upper limb while the child sitting on chair
Traditional seat 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.

Also known as: Occupational therapy program for upper limb while the child sitting on adaptive seating equipment ( swiss ball)
Adaptive seating equipment group

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy, Cairo university

Cairo, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Mai Abbass, Ph.D.

    Cairo University

    STUDY DIRECTOR
  • Ahmed Mahrous, Msc

    Cairo University

    PRINCIPAL INVESTIGATOR
  • Elham Salem, Ph.D.

    Cairo University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: study group and control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mai Elsayed Abbass

Study Record Dates

First Submitted

November 16, 2020

First Posted

December 3, 2020

Study Start

February 1, 2018

Primary Completion

August 15, 2018

Study Completion

August 30, 2018

Last Updated

December 3, 2020

Record last verified: 2020-11

Locations