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

Sponsor
Riphah International University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05916872
Collaborator
(none)
30
1
2
10.4
2.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: experimental group
  • Other: control group
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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)
Primary Purpose:
Treatment
Official Title:
Combined Effects of Proprioceptive Neuromuscular Facilitation and Electrical Muscle Stimulation on Spasticity and Hand Function in Stroke Patients.
Actual Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: experimental group

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

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

Active Comparator: control group

patients in groups B will receive conventional therapy.

Other: control group
Patients will receive conventional therapy.

Outcome Measures

Primary Outcome Measures

  1. Modified Barthel Index: [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.

  2. Modified Ashworth Scale: [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Riphah International University Islamabad Fedral Pakistan 44000

Sponsors and Collaborators

  • Riphah International University

Investigators

  • Principal Investigator: Zeest Hashmi, MSNMPT, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Riphah International University
ClinicalTrials.gov Identifier:
NCT05916872
Other Study ID Numbers:
  • REC/RCR & AHS/23/0211
First Posted:
Jun 23, 2023
Last Update Posted:
Jun 28, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Riphah International University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 28, 2023