Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04823936 |
| Other study ID # |
Faculty of Physcial therapy |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2018 |
| Est. completion date |
February 28, 2021 |
Study information
| Verified date |
March 2021 |
| Source |
Cairo University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Forty children with cerebellar ataxia ranged in age from five to nine years old, they were
randomly assigned into two matched control and study groups. The control groups received the
selected physical therapy program three times weekly one hour per session while the study
group received core stability training for 30 minutes in addition to the selected physical
therapy program. Both groups were evaluated by SARA Scale for the Assessment and Rating of
Ataxia, Balance Error Scoring Systems scale, Bruininks-Oseretsky test of motor Proficiency
2ed subtest 4 (bilateral coordination), and subtest 7 (upper limb coordination), and HUMAC
Balance System before and after two months of intervention.
Description:
Forty ataxic cerebral palsied children were selected from private pediatric physical therapy
centers, their ages ranged from five to nine years old. They were simply randomly assigned
into two matched control and study group via an electronic program (SPSS) as illustrated in
figure (1). The selected children had level IV according to the gross motor function
classification system and their ataxia severity score was less than 25 according to the scale
for the Assessment and Rating of Ataxia (SARA). Children have excluded it they had visual
impairment, spasticity, uncontrolled convulsions, any other neuromuscular diseases,
ataxia-telangiectasia, spinocerebellar ataxia, and Joubert syndrome.
Measures
1. Scale for the Assessment and Rating of Ataxia (SARA): it is a clinical scale that
assesses a range of different impairments in cerebellar ataxia. The scale is made up of
8 items related to gait, stance, sitting, speech, finger-chase test, nose-finger test,
fast alternating movements, and heel-shin test [22].
2. Balance Error Scoring Systems scale (BESS): This tool assesses postural control in
stable surfaces the tests performed on the ground and foam block. It composes of six
items performed with eyes closed taking 20 Sc each [23].
3. The Bruininks-Oseretsky Test of Motor Proficiency 2ed (BOT-2): It is a standardized,
norm-referenced measure used by physical therapists and occupational therapists in the
clinic and school practice settings. It is an individually administered test that
delivers a most precise measure of motor skills, both gross and fine, of children and
youth, 4 through 21 years of age [24].
4. HUMAC Balance System: Developed by Computer Sports Medicine, Inc. (CSMi), The HUMAC
Balance System is a high-quality computerized balance system. It is a static force plate
(Force Plate Mode) that measures Center of Pressure (COP) and Force [25].
1- Procedures for evaluation Both groups were evaluated before and after two months of
intervention by the SARA Scale for the Assessment and Rating of Ataxia, Balance Error Scoring
Systems scale, Bruininks-Oseretsky test of motor Proficiency 2ed subtest 4 (bilateral
coordination) and subtest 7 (upper limb coordination), and HUMAC Balance System.
2- Procedure for intervention The Control group received the selected physical therapy
program for one hour, three times weekly for two successive months including facilitation of
balance and protective reactions from kneeling, half kneeling and standing position, standing
alone on balance board, standing on one leg, open gait training alone (walking on the balance
beam, walking on the stepper and walking on wedges), training stair climbing, and
strengthening of the back and abdominal muscles.
The study group received the selected physical therapy program for one hour, three times
weekly in addition to core stability training program for 30 minutes [26]. The core stability
training program.
illustration of core stability program. Supine abdominal draw in 10- 15 times Abdominal draw
in with double knee to chest 10- 15 times Trunk twist while sitting on medical ball 10- 15
times Lying supine on the medical ball and rotating the trunk to the sides 10- 15 times
Contracting abdominal muscles while lying in a supine position and pulling the limbs upward
with arms and legs kept close 10- 15 times Bringing up the arms and legs simultaneously in
the prone position 10- 15 times Bridging with head on medical ball hold this position for 3-5
s then slowly relaxes 10- 15 times Bridging while shoulders and hands are on the floor and
one leg is raised 10- 15 times Lying supine on the medical ball and holding the abdomen in
and bringing with one leg up 10- 15 times
