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Combined Effects of PNF and Electrical Muscle Stimulation on Spasticity and Hand Function in Stroke Patients.

Primary Purpose

Stroke, Proprioceptive Disorders, Balance; Distorted

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
experimental group
control group
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Proprioceptive Disorders, Balance; Distorted

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Riphah International UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

experimental group

control group

Arm Description

patients in this group will receive contract relax exercises along with EMS

patients in groups B will receive conventional therapy.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 14, 2023
Last Updated
June 27, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05916872
Brief Title
Combined Effects of PNF and Electrical Muscle Stimulation on Spasticity and Hand Function in Stroke Patients.
Official Title
Combined Effects of Proprioceptive Neuromuscular Facilitation and Electrical Muscle Stimulation on Spasticity and Hand Function in Stroke Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Proprioceptive Disorders, Balance; Distorted
Keywords
Stroke, Proprioceptive Disorders, Balance; Distorted

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
patients will be allocated to two groups by randomization. Patients in Group A will receive Proprioceptive Neuromuscular Facilitation (contract-relax) technique & EMS patients in Group B will receive conventional therapy.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
patients in this group will receive contract relax exercises along with EMS
Arm Title
control group
Arm Type
Active Comparator
Arm Description
patients in groups B will receive conventional therapy.
Intervention Type
Other
Intervention Name(s)
experimental group
Intervention Description
Patients will receive Proprioceptive Neuromuscular Facilitation (contract-relax) technique with EMS
Intervention Type
Other
Intervention Name(s)
control group
Intervention Description
Patients will receive conventional therapy.
Primary Outcome Measure Information:
Title
Modified Barthel Index:
Description
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.
Time Frame
9 months
Title
Modified Ashworth Scale:
Description
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.
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zeest Hashmi, MS NMPT
Phone
03224655851
Email
zeest.hashmi@riphah.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Imran I Amjad, PhD
Phone
03324390125
Email
Imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeest Hashmi, MSNMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International University
City
Islamabad
State/Province
Fedral
ZIP/Postal Code
44000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Imran Amjad, PhD
Phone
03324390125
Email
Imran.amjad@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
waqas ahmad, MS NMPT

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25104481
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.
Results Reference
background
PubMed Identifier
8291967
Citation
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.
Results Reference
background
PubMed Identifier
24377757
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.
Results Reference
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Combined Effects of PNF and Electrical Muscle Stimulation on Spasticity and Hand Function in Stroke Patients.

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