Home » Trials » SLCTR/2025/026
Investigating the effectiveness of cyclic neuromuscular electrical stimulation with routine therapy in recovery of upper extremity functions in patients with early subacute stroke attending District General Hospital Negombo
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SLCTR Registration Number
SLCTR/2025/026
Date of Registration
The date of last modification
Jul 03, 2025
Scientific Title of Trial
Investigating the effectiveness of cyclic neuromuscular electrical stimulation with routine therapy in recovery of upper extremity functions in patients with early subacute stroke attending District General Hospital Negombo
Public Title of Trial
Investigating the effectiveness of Cyclic Neuromuscular Electrical Stimulation compared to routine exercise therapy on the upper extremity functions of patients with early subacute stroke attending District General Hospital Negombo
Disease or Health Condition(s) Studied
Stroke
Scientific Acronym
NONE
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1322-0867
Any other number(s) assigned to the trial and issuing authority
None
What is the research question being addressed?
Is Cyclic Neuromuscular Electrical Stimulation effective in improving the upper extremity functions of patients with early sub-acute stroke attending District General Hospital Negombo, in addition to routine exercise therapy?
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: Department of Physical Medicine, District General Hospital, Negombo Randomization: Simple Randomized Sampling
Male and Female Patients will be recruited between 7 days to 3 months after their first stroke, registered in the Department of Physical Medicine outpatient clinic. Participants with similar functional levels of the upper limb will be included in both control and treatment groups by using the Action research arm test cut-off score of 10. Participants who have receptive aphasia will be excluded from both the control and treatment groups.
Participants will be randomized into two groups, a control group and a treatment group, using a method of concealed random allocation. 1st participant will be allocated randomly to one of the two groups using the sealed envelope method, and the next participant will be allocated to the other group systematically based on the 1st participant’s selection, where participants do not know which group they belong to.
Blinding: This is a single-blinded study where the Data analyst and the Outcome assessor are blinded. A blind assessor will conduct the pre- and post-interventional assessments.
Intervention: Each participant in the treatment group will be given a 20-minute session of electrical stimulation called cyclic NMES and a subsequent routine exercise session for 20 minutes per day for five days per week for three weeks (a total of 15 sessions). The participants in the treatment group will be treated with electrical stimulation by the routinely used muscle stimulator in a general physiotherapy practice setting. Two surface electrodes will be placed on the muscles in the arm and forearm to produce movements in the arm and forearm. Each participant in the control group will receive 15 sessions of the same routine exercises, five days per week, for three weeks.
The principal investigator will conduct the treatment sessions. The interventions will be conducted on two different days to avoid discussions between the participants about the treatments received.
All the interventions will be supervised by the Principal Investigator, and if any discomfort is reported by any participant will be immediately discontinued.
Inclusion criteria
Male and Female patients at their early sub-acute stroke period, which is seven days from onset to three months, and are registered at the Department of Physical Medicine, District General Hospital, Negombo.
Male and Female patients with stroke above 18 years of age.
Male and Female patients with a first stroke and a cut-off score of 10 in the Action Research arm test.
Male and Female patients who have no contraindications to cyclic neuromuscular electrical stimulation
Female Patients who are pregnant and who become pregnant during the intervention, with the consent of their in-charge consultant.
Exclusion criteria
Medically unstable patients.
Patients who have a history of osteoarthritis, rheumatoid arthritis, or soft-tissue injuries resulting in contractures or a reduced range of movement in the wrist and fingers.
Patients underwent thrombolysis.
Patients who have receptive aphasia. After randomization, Patients who show discomfort with the intervention and patients who become medically unstable during the treatment will be excluded
Primary outcome(s)
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1.
Change in score of the Action Research Arm Test (ARAT) The Action Reach arm test consists of 19 items designed to assess four areas of function: grasp, grip, pinch, and gross movement. Each question is scored on an ordinal scale ranging from 0 (no movement) to 3 (normal performance of the task). In ARAT, a cut-off score of 10 points was decided upon because a score of 9 points mostly shows gross arm motions, whereas a score of 9 points always represents some hand function only. |
[ The measurement will be taken by this tool from each participant after enrollment on the first day before commencing the intervention and 15th day after completing the intervention for both treatment and control groups at the Department of Physiotherapy, District General Hospital Negombo. ] |
Secondary outcome(s)
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1.
Fugl-Meyer Assessment Upper Extremity (FMA-UE) This is an impairment measure used to assess locomotor function and control, including balance, sensation, and joint pain in patients post-stroke. It consists of four categories (Shoulder/Elbow/Forearm, Wrist, Hand/Finger, and Coordination) and includes 23 different movements that evaluate 33 items. The items are scored on a 3-point rating scale. |
[ The measurement will be taken by this tool from each participant after enrollment on the first day before commencing the intervention and 15th day after completing the intervention for both treatment and control groups at the Department of Physiotherapy, District General Hospital Negombo. ] |
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2.
Manual Muscle Testing In studies that specifically looked at the rater reliability of manual muscle testing in stroke survivors, it was found that experienced examiners were able to determine the degree of muscle weakening in a variety of diseases with excellent inter-rater reliability. |
[ The measurement will be taken by this tool from each participant after enrollment on the first day before commencing the intervention and 15th day after completing the intervention for both treatment and control groups at the Department of Physiotherapy, District General Hospital Negombo. ] |
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3.
Modified Barthel Index The index was initially intended to be used in assessing improvement during rehabilitation for patients with chronic neuromuscular or musculoskeletal disorders, and it is still used in this capacity today. Most frequently in populations recovering from stroke, a customized version has been utilized for inpatient rehabilitation assessments as a way to track functional changes. |
[ The measurement will be taken by this tool from each participant after enrollment on the first day before commencing the intervention and 15th day after completing the intervention for both treatment and control groups at the Department of Physiotherapy, District General Hospital Negombo. ] |
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4.
Active Range of Motion AROM against gravity is theoretically a rapid indicator of how well the spared motor system can engage the spinal motoneuron pools that move a particular segment in stroke survivors. It has been found that AROM values are predictive of subsequent upper extremity function, and if predictive power is sufficient, these values might be utilized to gauge the prognosis of arm function in certain individuals. |
[ The measurement will be taken by this tool from each participant after enrollment on the first day before commencing the intervention and 15th day after completing the intervention for both treatment and control groups at the Department of Physiotherapy, District General Hospital Negombo. ] |
Target number/sample size
62 (31 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2025-08-01
Anticipated end date
2025-10-01
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Self- Funded
Regulatory approvals
N/A
Status
Approved
Date of Approval
2025-04-25
Approval number
2024/EC/30
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Peradeniya |
| Institutional Address: | Faculty of Medicine, University of Peradeniya |
| Telephone: | 0812396361 |
| Email: | chairperson.erc@med.pdn.ac.lk |
Contact person for Scientific Queries/Principal Investigator
K.T.M.A.Fernando
Post Graduate Student (Msc in Physiotherapy
Department of Physiotherapy,
Faculty of Allied Health Sciences,
University of Peradeniya,
Augusta Hill,
Sri Amarawansa Mawatha,
Peradeniya
0812065784
0719455524
amindrafernando@yahoo.com
Contact Person for Public Queries
Dr. S.I. Wadugodapitiya
Senior Lecturer
Department of Physiotherapy, Faculty of Allied Health Sciences, University of Peradeniya, Augusta Hill, Sri Amarawansa Mawatha, Peradeniya
0812065784
0706676767
surangikw@gmail.com
headphysiotherapy@ahs.pdn.ac.lk
Primary study sponsor/organization
University of Peradeniya
Galaha Rd, 20400
0812 392 000
https://www.pdn.ac.lk/council-academic-division/
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
