- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07633249
Effect of Core Stability Training on Trunk Control and Sitting Balance in Patients With Paraplegia
Effect of Core Stability Training on Trunk Control and Sitting Balance in Patients With Paraplegia: A Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
This randomized controlled trial was conducted to evaluate the effectiveness of core stability training in improving trunk control and sitting balance in patients with paraplegia due to traumatic incomplete spinal cord injury. Forty-six participants diagnosed with incomplete SCI at neurological levels T6-T12 were randomly assigned into two groups. The study group received core stability training in addition to selected conventional physical therapy, while the control group received the same selected physical therapy program only.
Outcome measures included trunk control assessed by the Trunk Impairment Scale (TIS), sitting balance assessed by the Seated Functional Reach Test (SFRT) and T-shirt Test, and weight-bearing symmetry assessed using the Wii Balance Board (WBB). The study aimed to determine whether adding core stability training could significantly improve trunk control, sitting balance, and weight distribution symmetry in this population.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Giza Governorate
-
Giza, Giza Governorate, Egypt, 12613
- Faculty of physical therapy Cairo University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with traumatic incomplete SCI.
- Neurological level between T6 and T12 according to ASIA classification.
- Age from 25 to 35 years.
- Ability to maintain unsupported sitting.
- Medically stable condition.
- Adequate cognitive ability to follow instructions.
- Duration of injury more than six months.
- Moderate trunk impairment (TIS score 8-14).
- BMI less than 30 kg/m
Exclusion Criteria:
- other neurological disorders affecting balance.
- Uncontrolled cardiovascular conditions.
- Active lumbar or pelvic pressure sores.
- Orthopedic disorders affecting trunk control or sitting balance.
- Severe spasticity interfering with sitting balance
Study Plan
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 |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Group
Participants received selected conventional physical therapy program.
|
Patients received selected conventional physical therapy program in form of:
Treatment was conducted for about 60 minutes, three sessions per week for eight weeks |
|
Experimental: Study Group
Participants received the same selected conventional physical therapy program in addition to Core Stability Training.
|
Patients received selected conventional physical therapy program in form of:
Treatment was conducted for about 60 minutes, three sessions per week for eight weeks The core stability program consisted of progressive trunk stabilization exercises targeting deep trunk muscles. Training included:
The sessions were divided into 40-45 minutes of selected conventional physical therapy modalities and exercises, followed immediately by 15-20 minutes of progressive Core Stability Training (CST) targeting the deep stabilizing muscles of the trunk . |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight Distribution Symmetry (Wii Balance Board)
Time Frame: Baseline and after 8 weeks
|
Assessment of sitting weight-bearing symmetry using the Wii Balance Board by measuring the percentage of body weight distributed between the right and left sides.
|
Baseline and after 8 weeks
|
|
Trunk Impairment Scale (TIS)
Time Frame: Baseline and after 8 weeks
|
Assessment of trunk control through evaluation of static sitting balance, dynamic sitting balance, and trunk coordination.
Higher scores indicate better trunk performance.
|
Baseline and after 8 weeks
|
|
Seated Functional Reach Test (SFRT)
Time Frame: Baseline and after 8 weeks
|
Assessment of dynamic sitting balance by measuring maximum forward reaching distance while maintaining sitting stability.
|
Baseline and after 8 weeks
|
|
T-shirt Test
Time Frame: Baseline and after 8 weeks
|
Functional assessment of dynamic sitting balance and trunk coordination through timed dressing performance while seated.
|
Baseline and after 8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mohamed A Fathy, BSc, Cairo 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
- P.T.REC\012\006398)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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