Home » Trials » SLCTR/2025/032
The effect of sit-to-stand training combined with core strengthening on the balance and gait of the patient affected with stroke - a Randomised Controlled Trial
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SLCTR Registration Number
SLCTR/2025/032
Date of Registration
The date of last modification
Aug 22, 2025
Scientific Title of Trial
The effect of sit-to-stand training combined with core strengthening on the balance and gait of the patient affected with stroke - a Randomised Controlled Trial
Public Title of Trial
The effect of sit-to-stand training combined with core strengthening versus conventional exercises on the balance and gait and quality of life of the patient affected with subacute stroke
Disease or Health Condition(s) Studied
Stroke
Scientific Acronym
None
Public Acronym
None
Brief title
Effect of a specific exercise program on stroke patients
Universal Trial Number
U1111-1323-8864
Any other number(s) assigned to the trial and issuing authority
ERC number – 2025/EC/08 - Ethics Review Committee, Faculty of Medicine, University of Peradeniya
What is the research question being addressed?
Is sit-to-stand training combined with core strengthening more effective than conventional exercise in improving functional mobility and balance in subacute stroke patients?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded : Data analysts, Outcome assessors
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Applicable
Intervention(s) planned
Study Setting This study will employ a pretest-posttest experimental design with two arms, conducted over six weeks. The intervention will take place in a clinical or rehabilitation setting equipped with facilities for physiotherapy and functional training. All participants will be evaluated before and after the intervention period using standardized assessments.
Randomization Participants will be randomly assigned to either the experimental or control group. Randomization will be performed using the envelope method by a physical therapy assistant who is not involved in administering the outcome measures. This ensures allocation concealment and eliminates selection bias. Participants will be equally distributed between the two groups based on this random assignment process.
Participants will be selected according to inclusive criteria and participant selection will ensure that participants meet the inclusion and exclusion criteria and through evaluation including the Mini Mental State Evaluation (MMSE). Sit-to-stand training with core strengthening will be conducted in the experimental group. The control group will be given core-strengthening exercises. Both groups will be given get conventional exercises. All the participants will be measured before and after training for six weeks using the functional reach test, Burg balanced test , gait assessment and quality of life questionnaire.
Patients in the control group will be engaged in core strengthening activities, while patients in the experiment group will be engaged in core strengthening exercises as well as sit-to-stand training.
Training from sitting to standing. Subjects will be placed in a height-adjustable chair with the hips and knee joints at right angles. The sit-to-stand movement will be done without using your arms. After completing 10 repetitions, the subjects will be provided with one minute of rest. Individual education was given to the patients prior to the start of the trial. Treatment sessions will be given to both the experimental and control groups for a total of five weeks, with four sessions per week given to each participant. Both groups will receive the core strengthening exercise program, which will last roughly 30 minutes per session. However, an additional 15 minutes will be allotted to sit-to-stand training in the experimental group. Posttest will be done end of the sixth week
Inclusion criteria
• Male and female
• Aged older than 18 years.
• Willing to comply with all study procedures and be available for the study duration.
• Diagnosed with stroke confirmed through CT or MRI imaging.
• First-ever stroke with an onset within 1 to 6 months.
• Presence of clearly defined motor impairments, specifically unilateral moderate motor weakness affecting the lower limbs.
• Motor weakness confirmed by the Fugl Meyer Assessment during the initial evaluation.
• Ability to communicate and follow instructions.
• Score of at least 21 on the Mini-Mental State Examination (MMSE).
Exclusion criteria
• Presence of concurrent neurological disorders (e.g., Parkinson's disease).
• Significant orthopedic conditions affecting sitting balance.
• Psychological disorders that impair the ability to follow instructions.
• Heart failure or other conditions limiting physical activity.
•Currently undergoing treatments that could interfere with the study outcomes.
Primary outcome(s)
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1.
Berg Balance Scale (BBS): Tool Description: A 14-item scale that assesses static and dynamic balance abilities. Expected Outcome: Increase in BBS score indicating improved balance performance. Assessment Time: Pretest and posttest |
[ These measures will be taken on the first day before commencing the exercise program for both experimental and control group participants. ] |
|
2.
Functional Reach Test (FRT): Tool Description: Measures the maximum distance an individual can reach forward while standing in a fixed position. Expected Outcome: Increase in reach distance (inch) indicating improved balance and functional mobility. Assessment Time: Pretest and posttest |
[ These measures will be taken on the first day before commencing the exercise program for both experimental and control group participants. ] |
|
3.
Gait Assessment and Intervention Tool (G.A.I.T.): Tool Description: Assesses multiple components of gait, including movement symmetry, coordination, and quality. Expected Outcome: Improved gait component scores indicating better gait patterns and motor control. |
[ These measures will be taken on the first day before commencing the exercise program for both experimental and control group participants. ] |
|
4.
Quality of Life Questionnaire: Tool Description: Standardized questionnaire assessing physical, emotional, and social aspects of health. Expected Outcome: Improved quality of life scores, reflecting enhanced overall well-being. Assessment Time: Pretest and posttest |
[ These measures will be taken on the first day before commencing the exercise program for both experimental and control group participants. ] |
Secondary outcome(s)
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1.
None |
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Target number/sample size
70 (35 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2025-08-31
Anticipated end date
2025-09-01
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None (Investigator funded)
Regulatory approvals
Not Applicable
Status
Approved
Date of Approval
2025-05-29
Approval number
2025/EC/08
Details of Ethics Review Committee
| Name: | Ethical Review committee, Faculty of Medicine ,University of Peradeniya |
| Institutional Address: | Faculty of Medicine, University of Peradeniya Peradeniya. |
| Telephone: | +0812396361 |
| Email: | chairperson.erc@med.pdn.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Lihinikadugamage Kithmini Kasunka
Postgraduate student (Msc in Physiotherapy)
Department of Physiotherapy
Faculty of Allied Health Sciences,
University of Peradeniya,
Augusta Hill,Sri Amarawansa Mawatha,
Peradeniya
TEl: +0813999623
Mob: 0774383223
Fax: :+94-81-2387394
Email: kithminikasunka@gmail.com
ahs.pdn.ac.lk.
Contact Person for Public Queries
Dilhari Senarath
Senior Lecturer
Department of Physiotherapy, Faculty of Allied Health Sciences, University of Peradeniya
Tel: +94 81 2065784
Fax: +94 81 2387394
dilharisenarath@ahs.pdn.ac.lk; headphysiotherapy@pdn.ac.lk
https://www.health.gov.lk/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
