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CompletedNCT04651283hemiparesisUpdated Dec 3, 2020

Effect of Using Adaptive Seating Equipment on Hand Function

An interventional study of Traditional seat group and Adaptive seating equipment group in Cerebral Palsy, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 3 Years to 6 Years. Per ClinicalTrials.gov, last updated 2020-12-03.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 9 months after the study started (first participant enrolled Feb 2018, registered Nov 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
3 Years to 6 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Cerebral Palsy

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03

In context

Cerebral Palsy

1,853 studies on the registry are indexed under Cerebral Palsy; 435 are open to participants now.

This study's enrollment of 30 is close to the median of 33 across 1,368 interventional studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherTraditional 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.

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

  • OtherAdaptive 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.

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

06

What researchers measure

Primary outcomes

  1. change is being assessed in grasping score

    Assessment of grasping using Peabody Developmental Motor Scale 2 the higher score means a better outcome

    Time frame: Change from Baseline grasping score assessed at 3 months

  2. 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

    Time frame: Change from Baseline visual motor integration score assessed at 3 months

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Study locations

1 site
  • Faculty of physical therapy, Cairo university
    Cairo, Egypt
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04651283
Lead sponsor
Cairo University
Responsible party
Mai Elsayed Abbass (Mai Elsayed Abbass, Cairo University) — Principal investigator
First posted
Dec 3, 2020
Start date
Feb 1, 2018
Primary completion
Aug 15, 2018
Completion
Aug 30, 2018
Last update
Dec 3, 2020

Study contacts

Mai Abbass, Ph.D.
study director · Cairo University
Ahmed Mahrous, Msc
principal investigator · Cairo University
Elham Salem, Ph.D.
study chair · Cairo University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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