Home » Trials » SLCTR/2024/029
Effects of functional electrical stimulation (FES) for the motor functions of upper limb and activities of daily living (ADLs) in acute and sub-acute stroke patients.
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SLCTR Registration Number
SLCTR/2024/029
Date of Registration
The date of last modification
Oct 21, 2024
Scientific Title of Trial
Effects of functional electrical stimulation (FES) for the motor functions of upper limb and activities of daily living (ADLs) in acute and sub-acute stroke patients.
Public Title of Trial
Effects of functional electrical stimulation (FES) compared to Conventional physiotherapy treatments for the motor functions of upper limb and activities of daily living (ADLs) in acute and sub-acute stroke patients.
Disease or Health Condition(s) Studied
Stroke
Scientific Acronym
None
Public Acronym
None
Brief title
Effects of Functional Electrical Stimulation for stroke patients.
Universal Trial Number
U1111-1309-4030
Any other number(s) assigned to the trial and issuing authority
ERC/2024/15 (University of Rajarata)
What is the research question being addressed?
Is Functional Electrical Stimulation (FES) effective compared to Conventional physiotherapy treatments for improving the motor functions of upper limb and activities of daily living (ADLs) in acute and sub-acute stroke patients?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded : Participants, Outcome assessors
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Applicable
Intervention(s) planned
• Study setting - Neurology and Neuro-surgery Physiotherapy Unit, Teaching Hospital, Anuradhapura. • Randomization - 1:1 randomization using sealed envelopes. • Intervention - Functional Electrical Stimulation. Functional Electrical Stimulation (FES) is the electrical stimulation applied to a muscle during a voluntary movement. FES consists of the application of moderate-intensity and cyclic electrical stimulation over selected muscles to generate functional movements that mimic voluntary contractions and to restore functions that were lost by facilitating motor re-learning. Electrodes are placed over the nerve(s) innervating the muscle to be stimulated and stimulation is delivered. The intensity of the stimulation will determine by which muscles are contracted as well as the strength of their contraction. • Treatment group - Functional electrical stimulation will be performed by the principal investigator over the shoulder flexors (Biceps), elbow extensors (Triceps) and wrist and finger extensors (posterior forearm). Treatment will be continued for 40 minutes a day 3 days a week for 8 weeks. • Control group - sham FES will be performed by the principal investigator over the same muscle groups as in treatment group for 40 minutes a day 3 days a week for 8 weeks. • Both groups will receive conventional physiotherapy program (Standard therapy program) for 30 minutes a day, 3 days a week, for 8 weeks. Standard physiotherapy program will be given to both interventional and control groups. The conventional physiotherapy programme will include positioning, trunk training exercises, active/ passive range of motion exercises, stretching and strengthening exercises, functional task specific repetitive training, gait training and progressive balance training. • Blinding - Both patients and outcome assessors will be blinded to the treatments, and patients will remain unaware of whether they are receiving active or sham Functional Electrical Stimulation.
Inclusion criteria
• Age between 18 to 70 years • Both male and female • Post stroke hemiparesis • First unilateral stroke with upper limb involvement. • Acute and sub-acute stroke patients up to 6-month period from onset • Both hemorrhagic/ischemic stroke patients • Modified Ashworth scale (MAS) score 2 or less than 2 at wrist and elbow. • Sufficient cognitive ability to follow instructions.
Exclusion criteria
• Contraindicated for Functional Electrical stimulation (FES) which include: Poor skin condition (pressure sores, sensitive skin for self-adhesive electrodes) Poorly controlled epilepsy Current pregnancy: Cardiac pacemakers Cancerous tumor: Metal implants: Unhealed fracture. Suspected, diagnosed, or uncontrolled Cardio-vascular conditions: Severe muscle spasticity or contractures. Botulinum toxin
• Presence of psychological or emotional issues depend on medical diagnosis due to current condition or any previous illness. • Presence of previous history of head injury, trauma or concussions. • Any other associated Musculoskeletal or Neurological conditions which might affect upper limb functions. • Numeric Pain Scale >7 (NPS) • Visual defects • Inability to sit in a standard armless chair for at least 40 min • Currently having other treatment options other than medical treatments.
Primary outcome(s)
1.
Motor functional recovery of upper limb within 8 weeks will be measured by using Fugl Meyer Assessment Upper Extremity. It is tool which assesses performance-based, quantitative measures of motor impairment of upper limb. It is designed to assess motor functions, sensations and joint functioning in post stroke hemiplegia. The components as follows. A- Upper Extremity reflex activities and movement patterns (volitional movements within synergies, mixing synergies, and little or no synergies) B- Wrist movement patterns C- Hand Mass movements and grasp patterns D- Coordination/Speed, Tremor, Dysmetria and Time. |
[ • Before the application of intervention, in both treatment and control groups. (Baseline measurements) • After the application of intervention in both groups at the end of 8th week. ] |
2.
Motor functional abilities of upper limb will be measured by using Wolf motor function test (WMFT). This measures the upper extremity motor ability through timed and functional tasks in individuals with upper extremity functional deficits. The WMFT consists of 17 items and composed of 3 parts: 1. Time 2. Functional ability 3. Strength |
[ • Before the application of intervention, in both treatment and control groups. (Baseline measurements) • After the application of intervention in both groups at the end of 8th week. ] |
Secondary outcome(s)
1.
|
[ • Before the application of intervention, in both treatment and control groups. (Baseline measurements) • After the application of intervention in both groups at the end of 8th week. . ] |
Target number/sample size
72 (36 for each group)
Countries of recruitment
Sri Lanka
Anticipated start date
2024-08-30
Anticipated end date
2024-11-15
Date of first enrollment
2024-09-01
Date of study completion
Recruitment status
Recruiting
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2024-06-12
Approval number
ERC/2024/15
Details of Ethics Review Committee
Name: | Ethics Review Committe, Faculty of Medicine and Allied Sciences, Rajarata university of Sri Lanka |
Institutional Address: | Rajarata University of Sri Lanka, Saliyapura, Sri Lanka |
Telephone: | +94(0)252053633 |
Email: | erc@med.rjt.ac.lk |
Contact person for Scientific Queries/Principal Investigator
D.M.J.K.Dinasena
Physiotherapist
Teaching Hospital Anuradhapura
+94(0)252222261
+94716973499
jeewanidinasena@gmail.com
Contact Person for Public Queries
Dr Dhanushka Hewabosthanthirige
Senior Lecturer
Department of Allied Health Sciences
Faculty of Medicine
University of Colombo
+94252234465
+94717507307
dhanushka@med.rjt.ac.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
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