- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03626077
Biofeedback Training and Physical Therapy Program Improves Visual-motor Integration in Children With Cerebral Palsy
Augmented Biofeedback Training Combined With Physical Therapy Program Improves Visual-motor Integration, Visual Perception and Motor Coordination in Children With Spastic Hemiplegic Cerebral Palsy: a Randomized Control Trial
Study Overview
Status
Conditions
Detailed Description
Children were assigned randomly into three groups of equal number (A, B and C). Children were selected randomly by collecting all names of children that matched the inclusion criteria of the study then upload the names and gender using an electronic program (SPSS) which divided the sample into three equal groups (A), (B) & (C).
Group A: this group included fifteen children with spastic hemiplegic CP. Children of this group received specially designed program of physical therapy exercises to facilitate eye-hand coordination and fine motor to improve VMI, VP and MC, which included: unbutton buttons, and button in all again; put the pellets in the bottle as fast as he/she can; place the shapes on its form board; build steps, wall, pyramid and a tower from cubes; cut out a line, square, triangle, and rectangular shapes on a paper by scissor; string squared cubes and lace the holes of strip. The tools used in training program were: button strip, lacing strip and its lace, mottle with screw- on cap, markers with different colors, beads and its lacing, square cubes, pellets, papers, blunt scissors, colored cubes, different types of form board and its shapes. Adjusted chair and table were used to accommodate differences in children's body built. Children were trained for 60 minutes per session, three times a week for three consecutive months.
Group B: this group included fifteen children with spastic hemiplegic CP. Children of this group received training using the E-Link Upper Limb Exerciser for 60 minutes per session, three times a week for three consecutive months.
Group C: this group included fifteen children with spastic hemiplegic CP. Children of this group received the same physical therapy program as conducted for group A, and training with E-Link Upper Limb Exerciser as conducted for group B. The training was for 60 minutes per session, three times a week for three consecutive months.
The participated children were assessed by Beery-Buktenica Developmental Test before and after the three months of the treatment program. The average time required for evaluating each child was 40 min. The assessment and training methods were applied according to the instructions provided in the test and equipment manuals, no modifications were necessary.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alnakeel
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Riyadh, Alnakeel, Saudi Arabia, 11055
- Disabled Children's Association
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- grade of spasticity between 1 to 1+ according to Modified ashworth Scale, the ability to handle objects independently was between level (I) and (II) according to Manual Ability Classification System (MACS), no history of epilepsy; no botulinum toxin A treatment for the upper extremities in the previous 6 months, and able to understand and follow verbal commands and instructions
Exclusion Criteria:
- presence of visual or auditory impairments, significant tightness or fixed deformities in the upper limbs, severe spasticity, autism, or severe cognitive impairment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: group A
Group (A) physical therapy program for 60 minutes per session, three times a week for three consecutive months
|
this group received specially designed physical therapy program to facilitate eye-hand coordination and fine motor to improve VMI, VP and MC, which included: unbutton buttons, and button in all again; put the pellets in the bottle as fast as he/she can; place the shapes on its form board; build steps, wall, pyramid and a tower from cubes; cut out a line, square, triangle, and rectangular shapes on a paper by scissor; string squared cubes and lace the holes of strip.Children were trained for 60 minutes per session, three times a week for three consecutive months.
|
ACTIVE_COMPARATOR: group B
Group (B) E-Link Upper Limb Exerciser (augmented biofeedback training)for 60 minutes per session, three times a week for three consecutive months
|
The exercises in the E-Link Upper Limb Exerciser System are in the form of simple and exciting games such as soccer, hitting walls, space shooting, driving, arnd throwing balls into a bucket.Children were trained for 60 minutes per session, three times a week for three consecutive months.
|
EXPERIMENTAL: group C
group (C) physical therapy program and E-Link Upper Limb Exerciser
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physical therapy program and E-Link Upper Limb Exerciser.
Children were trained for 60 minutes per session, three times a week for three months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Beery-Buktenica Developmental Test of Visual-Motor Integration (6th edition) "change" is being assessed
Time Frame: 10-15 minutes total, it is taken at baseline and after 3 months of treatment
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it evaluate the subject's ability to integrate visual and motor skills, through copying
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10-15 minutes total, it is taken at baseline and after 3 months of treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Beery-Buktenica Developmental Test- Visual Perception test. "change" is being assessed
Time Frame: 5 minutes, it is taken at baseline and after 3 months of treatment
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it evaluates subject visual perception (VP) and motor coordination matching shapes to stimulus form
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5 minutes, it is taken at baseline and after 3 months of treatment
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Beery-Buktenica Developmental Test-Motor Coordination test. "change" is being assessed
Time Frame: 5 minutes, it is taken at baseline and after 3 months of treatment
|
it evaluates subject motor coordination through tracing within a confined space
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5 minutes, it is taken at baseline and after 3 months of treatment
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Collaborators and Investigators
Investigators
- Principal Investigator: Reem M Alwhaibi, PhD, Princess Nourah bint Abdulrahman University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 205-S-37
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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