- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05916872
Combined Effects of PNF and Electrical Muscle Stimulation on Spasticity and Hand Function in Stroke Patients.
Combined Effects of Proprioceptive Neuromuscular Facilitation and Electrical Muscle Stimulation on Spasticity and Hand Function in Stroke Patients.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Fedral
-
Islamabad, Fedral, Pakistan, 44000
- Riphah International University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Both ischemic and haemorrhagic stroke patients
- Chronic stroke patients from 6 month to 2years
- Mini Mental Scale Examination (MMSE) more than 25
Exclusion Criteria:
- Transient ischemic attack
- Recurrent stroke
- Stroke patient with comorbidity and cardiac disease
- Myopathies
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: control group
patients in groups B will receive conventional therapy.
|
Patients will receive conventional therapy.
|
|
Experimental: experimental group
patients in this group will receive contract relax exercises along with EMS
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Patients will receive Proprioceptive Neuromuscular Facilitation (contract-relax) technique with EMS
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified Barthel Index:
Time Frame: 9 months
|
It is used for assessing the activities of daily living.
It is composed of 10 questions that link the degree of independence to daily living activities.
Collin et, al; proposed amendment in 1988, in which each domain was scored in one-point increments, ranging from 0 to 2 or 3 for each activity with a maximum score of 20 suggesting functional independence.
It is highly reliable and has a good correlation with other disability measures.
|
9 months
|
|
Modified Ashworth Scale:
Time Frame: 9 months
|
Modified Ashworth Scale: It is used to assess the spasticity in patients of stroke or spinal cord injury. Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity. It is characterized by exaggerated deep tendon reflexes that interfere with muscular activity, gait, movement, or speech. It has excellent validity and reliability. |
9 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Zeest hashmi, MSNMPT, Riphah International University
Publications and helpful links
General Publications
- Rong W, Tong KY, Hu XL, Ho SK. Effects of electromyography-driven robot-aided hand training with neuromuscular electrical stimulation on hand control performance after chronic stroke. Disabil Rehabil Assist Technol. 2015 Mar;10(2):149-59. doi: 10.3109/17483107.2013.873491. Epub 2013 Dec 31.
- Faghri PD, Rodgers MM, Glaser RM, Bors JG, Ho C, Akuthota P. The effects of functional electrical stimulation on shoulder subluxation, arm function recovery, and shoulder pain in hemiplegic stroke patients. Arch Phys Med Rehabil. 1994 Jan;75(1):73-9.
- Hankey GJ. The global and regional burden of stroke. Lancet Glob Health. 2013 Nov;1(5):e239-40. doi: 10.1016/S2214-109X(13)70095-0. Epub 2013 Oct 24. No abstract available.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/23/0211
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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