The aim of the study is to find the compare the effects of electrical stimulation with and without motor re-learning programme on spasticity and upper limb function in stroke patients
Design
Two arm parallel group randomized trial , single blind , of 62 stroke patients
Settings and conduct
Sir Ganga Ram Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria was as follows:
• 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
Exclusion Criteria:
• 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
Intervention groups
Both groups will receive 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. Electrical stimulation will be used to stimulate flexion and extension of wrist and elbow. In Group A participants will receive electrical stimulation with motor relearning programme which consist of 4 steps as Step 1: Analysis of Task
Step 2: Practice of missing component
Step 3: Practice of Task
Step 4: Transference of training
In Group B Electrical stimulation without motor re-learning programme will be given. This protocol will be as 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. These exercises which can be performed for 5-10 repetitions depending on patient's capacity.
Main outcome variables
Spasticity
Upper limb function
neurological function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240914063038N1
Registration date:2024-09-26, 1403/07/05
Registration timing:registered_while_recruiting
Last update:2024-09-26, 1403/07/05
Update count:0
Registration date
2024-09-26, 1403/07/05
Registrant information
Name
Nimra Zulfaqar
Name of organization / entity
University of Lahore
Country
Pakistan
Phone
+92 324 4569208
Email address
nimrazulfaqar1122@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-07, 1402/12/17
Expected recruitment end date
2024-10-10, 1403/07/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Electrical Stimulation in addition to motor Re-learning Programme on Spasticity and Upper limb Function in Stroke Patients
Public title
Electrical Stimulation in addition to motor Re-learning Programme on Spasticity and Upper limb Function in Stroke Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 25 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
Blinding description
This study is a single blinded study in which outcome assessor will be unaware of the treatment group
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of University of Lahore
Street address
University of Lahore Teaching Hospital Lahore , Punjab , Pakistan
City
Lahore
Postal code
55150
Approval date
2024-02-15, 1402/11/26
Ethics committee reference number
REC-UOL-672-03-2024
Health conditions studied
1
Description of health condition studied
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.
ICD-10 code
I63.30
ICD-10 code description
Cerebral infarction due to thrombosis of unspecified cerebral artery
Primary outcomes
1
Description
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
2
Description
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.
Secondary outcomes
1
Description
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)
Intervention groups
1
Description
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
Category
Other
2
Description
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
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sir Ganga Ram Hospital
Full name of responsible person
Momna Asghar
Street address
Mozang Rd,Block B jinnah Town, Lahore ,Punjab 54000
City
Lahore
Postal code
55150
Phone
+92 304 7487995
Email
momnaasghar@uipt.uol.edu.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Lahore
Full name of responsible person
Nimra Zulfaqar
Street address
University of Lahore Teaching Hospital Lahore , Punjab , Pakistan
City
Lahore
Postal code
55150
Phone
+92 324 4569208
Email
nimrazulfaqar4569@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
None
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Nimra Zulfaqar
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
University of Lahore Teaching Hospital Lahore , Punjab , Pakistan
City
Lahore
Province
Punjab
Postal code
55150
Phone
+92 324 4569208
Email
nimrazulfqar4569@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Nimra Zulfaqar
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
University of Lahore Teaching Hospital Lahore , Punjab , Pakistan
City
Lahore
Province
Punjab
Postal code
55150
Phone
+92 324 4569208
Email
nimrazulfqar4569@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Nimra Zulfaqar
Position
Punjab
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
University of Lahore Teaching Hospital Lahore , Punjab , Pakistan
City
Lahore
Province
Punjab
Postal code
55150
Phone
+92 324 4569208
Email
nimrazulfqar4569@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Demographic data and data related to final outcome will be shared by maintaining the confidentially
When the data will become available and for how long
Data will be available after the publication after the publication of findings till six months
To whom data/document is available
Nimra Zulfaqar
Under which criteria data/document could be used
For research purpose
From where data/document is obtainable
To the correspomding author of the stuyd , Nimra Zulfaqar and can contact on +92324569208 nimrazulfqar4569@gmail.com
What processes are involved for a request to access data/document
Open access and thee is the traditional public data release where anyone can get access to the data