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IRCT20240914063038N1 IRCT 2024-09-26 University of Lahore Electrical Stimulation in addition to motor Re-learning Programme on Spasticity and Upper limb Function in Stroke Patients Electrical Stimulation in addition to motor Re-learning Programme on Spasticity and Upper limb Function in Stroke Patients 2024-03-07 anticipated 62 Complete https://irct.ir/trial/79084 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization will be used by one of the research team members who will be blinded to study and will not be involved in patient recruitment. Participants will be randomly allocated into two groups through lottery method, Blinding description: This study is a single blinded study in which outcome assessor will be unaware of the treatment group. 2-3 Stroke is a neurological disorder characterized by blockage of blood vessels. Clots form in the brain and interrupt blood flow, clogging arteries and causing blood vessels to break, leading to bleeding. Rupture of the arteries leading to the brain during stroke results in the sudden death of brain cells owing to a lack of oxygen.. Intervention 1: Intervention Group : Group A will be received electrical stimulation for 15 minutes with hot pack and the stretching of muscles will be performed at the end. The sessions will be last 60 minutes five days a week for an 8-week period. The parameter of the stimulation (Comfystim®) will be included a frequency of 35HZ,Synced option of EMS, pulse width of 250µ, Asymmetrical biphasic waveform, duty cycle of 5 secs on and 5secs off, and the amplitude was adjusted to the maximal tolerance of patient .To stimulate wrist flexion, active electrode was placed over the flexor carpi radials and the indifferent electrode over the flexor carpi ulnaris. To stimulate Elbow flexion, active electrode over the biceps and the indifferent electrode over the brachialis. To stimulate wrist and finger extension the active electrode will be positioned over extensor digitorum communis (EDC) and the indifferent electrode over extensor pollicis longus (EPL) and abductor pollicis longus (AbPL). To stimulate extension of the arm, active electrode will be placed over the anterior deltoid and the indifferent electrode over the triceps.The participants randomly will be allocated in Group A received the Motor Re-learning Programme with electrical stimulation. Motor re-learning programme which included different types of task specific exercises (3 reps & 10 times) will be performed. This motor re-learning programme includes following steps as treatment plans : Step 1: Analysis of Task Step 2: Practice of missing component Step 3: Practice of Task Step 4: Transference of training. Intervention 2: Intervention group B: In Group B Electrical stimulation without motor re-learning programme will be given for 60 mins on the upper limb for five days per week for a period of 8th weeks. First 15 minutes’ hot pack with electrical stimulation will be applied. The stimulation parameters and electrode placements will be the same as those previously mentioned. And upper limb Stretches of long finger flexors, Wrist flexors, Thumb adductors, Forearm pronators, Adductors and Internal rotators of GH joint were performed. Home Based Programme: This protocol will be including different exercises like Wrist flexion and extension, Finger flexion and extension, Forearm supination and pronation, tapping table top with all fingers, Opening of all fingers and Counting with fingers. Yes - There is a plan to make this available What will be shared: Demographic data and data related to final outcome will be shared by maintaining the confidentially When: Data will be available after the publication after the publication of findings till six months To whom: Nimra Zulfaqar Conditions: For research purpose Where to obtain: To the correspomding author of the stuyd , Nimra Zulfaqar and can contact on +92324569208 nimrazulfqar4569@gmail.com How to obtain: Open access and thee is the traditional public data release where anyone can get access to the data Comments:
public Nimra Zulfaqar
University of Lahore Teaching Hospital Lahore , Punjab , Pakistan
Lahore Pakistan 55150 +92 324 4569208 nimrazulfqar4569@gmail.com University of Lahore scientific Nimra Zulfaqar
University of Lahore Teaching Hospital Lahore , Punjab , Pakistan
Lahore Pakistan 55150 +92 324 4569208 nimrazulfqar4569@gmail.com University of Lahore Pakistan Aged between 25-65 years Both Male and females Stroke Onset ≥3 months Ischemia Stroke Patients with limb spasticity equal to 2 or less than 2 on modified Ashworth scale Patients with English reading and writing skills 25 years 65 years Both Patients with visual and auditory defects Patients with severe shoulder or wrist pain Patients with upper limb fractures/dislocations Contraindication to Electrical stimulation such as skin allergy I63.30 Cerebral infarction due to thrombosis of unspecified cerebral artery Other Other Intervention Group : Group A will be received electrical stimulation for 15 minutes with hot pack and the stretching of muscles will be performed at the end. The sessions will be last 60 minutes five days a week for an 8-week period. The parameter of the stimulation (Comfystim®) will be included a frequency of 35HZ,Synced option of EMS, pulse width of 250µ, Asymmetrical biphasic waveform, duty cycle of 5 secs on and 5secs off, and the amplitude was adjusted to the maximal tolerance of patient .To stimulate wrist flexion, active electrode was placed over the flexor carpi radials and the indifferent electrode over the flexor carpi ulnaris. To stimulate Elbow flexion, active electrode over the biceps and the indifferent electrode over the brachialis. To stimulate wrist and finger extension the active electrode will be positioned over extensor digitorum communis (EDC) and the indifferent electrode over extensor pollicis longus (EPL) and abductor pollicis longus (AbPL). To stimulate extension of the arm, active electrode will be placed over the anterior deltoid and the indifferent electrode over the triceps.The participants randomly will be allocated in Group A received the Motor Re-learning Programme with electrical stimulation. Motor re-learning programme which included different types of task specific exercises (3 reps & 10 times) will be performed. This motor re-learning programme includes following steps as treatment plans : Step 1: Analysis of Task Step 2: Practice of missing component Step 3: Practice of Task Step 4: Transference of training Intervention group B: In Group B Electrical stimulation without motor re-learning programme will be given for 60 mins on the upper limb for five days per week for a period of 8th weeks. First 15 minutes’ hot pack with electrical stimulation will be applied. The stimulation parameters and electrode placements will be the same as those previously mentioned. And upper limb Stretches of long finger flexors, Wrist flexors, Thumb adductors, Forearm pronators, Adductors and Internal rotators of GH joint were performed. Home Based Programme: This protocol will be including different exercises like Wrist flexion and extension, Finger flexion and extension, Forearm supination and pronation, tapping table top with all fingers, Opening of all fingers and Counting with fingers The Modified Ashworth Scale is a clinical assessment tool used to measure the spasticity of muscles in individuals with neurological conditions, such as cerebral palsy, stroke, multiple sclerosis, or spinal cord injuries. Timepoint: 8th weeks. Method of measurement: The Modified Ashworth Scale typically uses a 6-point grading system to assess muscle tone.The csale ranges from 0 to 4 with an additional grade of 1+. Where 0 means normal and 4 severe spasticity. The Motor evaluation scale for upper extremity in stroke (MESUPES) measures quality of movement performance of the hemiparetic arm and hand in stroke patients. MESUPES is comprised of 17 items in two subscales: MESUPES–Arm function: 8 items with 6 response categories (0-5) and other one is MESUPES–Hand function: 9 items with 3 response categories (0-2). Timepoint: 8th weeks. Method of measurement: The maximum achievable score is 58 (MESUPES-Arm maximum score is 40; MESUPES-Hand maximum score is 18). The patient is awarded one score for each task, and the highest score is retained. A score of 0 is awarded when the patient demonstrated inadequate tone, abnormal muscle contractions, synergic (flexor/extensor) or mass movement patterns. The National Institutes of Health Stroke Scale (NIHSS) is a widely used clinical tool for assessing the severity of stroke-related neurological deficits. It was developed by the National Institute of Neurological Disorders and Stroke (NINDS) and is utilized to evaluate the status of patients who have experienced a stroke or other cerebrovascular events. Timepoint: 8th weeks. Method of measurement: The NIHSS consists of a series of 11 neurological examination items, and each item assesses specific functions related to different areas of the brain. Each item is scored on a scale from 0 to 3 or 0 to 4, depending on the specific item. A higher score indicates a more severe neurological deficit. The scores from each item are then added together to give a total NIHSS score, which can range from 0 (no stroke-related deficits) to 42 (maximum severity). (Zöllner et al., 2020). None Approved 2024-02-15 Research Ethics Committee of University of Lahore University of Lahore Teaching Hospital Lahore , Punjab , Pakistan Lahore Punjab Pakistan