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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05916872
Other study ID # REC/RCR & AHS/23/0211
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2022
Est. completion date September 15, 2023

Study information

Verified date October 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To determine the combined effects of proprioceptive neuromuscular facilitation and electrical muscle stimulation on spasticity and hand function in stroke patients.


Description:

It will be a randomized controlled trial. The stroke patients aged between 30-70 years will be included in this study. Participants will be selected with non-probability convenience sampling technique. Participants will be randomly allocated into two groups by lottery method i.e experimental group and control group. The experimental group will receive proprioceptive neuromuscular technique (contract relax-10 repetition) (5-min) and electrical muscle stimulation(10 min) as 15 min session 3 times a week for four weeks while the control group will receive only conventional therapy. The outcome measure will be calculated by modified barthel index, modified ashworth scale and wolf motor function test.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date September 15, 2023
Est. primary completion date September 1, 2023
Accepts healthy volunteers No
Gender All
Age group 30 Years to 70 Years
Eligibility 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 Design


Intervention

Other:
experimental group
Patients will receive Proprioceptive Neuromuscular Facilitation (contract-relax) technique with EMS
control group
Patients will receive conventional therapy.

Locations

Country Name City State
Pakistan Riphah International University Islamabad Fedral

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Modified Barthel Index: 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
Primary Modified Ashworth Scale: 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
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