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

29 Aug 2024

The date of last modification

Oct 21, 2024



Application Summary


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)


Trial Details


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.
  1. Mean changes in scores using the Modified Barthel Index. This is an ordinal scale used to measure performance in activities of daily living.
    The MBI includes 10 personal activities:
  2. Feeding
  3. Personal hygiene.
  4. Bathing. 4.Dessing and undressing
  5. Toilet transfers.
  6. Controlling bladder.
  7. controlling bowel
  8. Chair to bed transfers and returning.
  9. Walking on level surface (or propelling a wheelchair if unable to walk)
  10. Ascending and descending stairs.
[

• 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



State of Ethics Review Approval


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 & Sponsor Information


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


Primary study sponsor/organization

Faculty of Allied Health Sciences, University of Peradeniya

Faculty of Allied Health Sciences University of Peradeniya Peradeniya Sri Lanka
+94812065775
+94812387394

Secondary study sponsor (If any)







Trial Completion details


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