TENS Effect on Gait and QoL in Stroke.

November 3, 2024 updated by: Amina Awad,PhD, Cairo University

Effect of Transcutaneous Electrical Nerve Stimulation Applied to Acupuncture Points on Gait and Quality of Life in Stroke Patients: a Randomized Controlled Study.

A study was conducted to investigate the additional effect of TENS applied to acupuncture points to the physical therapy program on gait and quality of life in stroke patients.

Thirty stroke patients from both sexes aging from 40 to 65 years were randomly assigned into two equal groups: study group and control group. The study group received TENS plus the designed physiotherapy program and the control group received only the same designed physiotherapy program. The outcome measures concerned with spasticity, gait and QoL.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A RCT study conducted to investigate the additional effect of TENS applied to acupuncture points to the physical therapy program on gait and quality of life in stroke patients. The study was conducted at the outpatient clinic of Faculty of Physical Therapy, Cairo University and Kasr El-Ainy Hospitals, Faculty of Medicine, Cairo University, Egypt.

Forty subjects were screened for eligibility but only thirty stroke patients from both sexes aging from 40 to 65 years who were included and randomly assigned into two equal groups: study and control group. The study group received TENS plus the designed physiotherapy program and the control group received only the same designed physiotherapy program. Patients were treated three times weekly for four weeks.

The outcome measures included the Modified Ashworth Scale (MAS) for assessing spasticity, the WHOQOL-BREF scale for evaluating QoL and the Biodex Gait Trainer for measuring the gait kinematics. Evaluation of all variables took place pretreatment and post treatment.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Giza
      • Cairo, Giza, Egypt, 12654
        • Faculty of physical therapy Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Clinical diagnosis of chronic stroke disease (6-8- months)
  • Age 45-60 years old
  • Mild to moderate spasticity
  • Can walk 10 meters independently
  • Sufficient cognitive abilities

Exclusion Criteria:

  • Other neurological diseases
  • Severe spasticity
  • Cognitive impairments
  • Medical instability
  • Sever arthritis or contractures
  • Cardio-pulmonary disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention arm
TENS applied to acupuncture points in addition to physical therapy program
Device: Transcutaneous electrical nerve stimulation (TENS)
TENS is applied on the acupuncture points Intervention arm
Other: Physical Therapy program
Physical therapy methods
Active Comparator: control arm
only physical therapy program
Other: Physical Therapy program
Physical therapy methods

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Ashworth scale (MAS)
Time Frame: • "At baseline and at the end of treatment at 4 weeks"
Spasticity assessment scale. Score (0-4) 0 means no increase in tone. 4 means rigidity The lower the score, the lower spasticity the patient has.
• "At baseline and at the end of treatment at 4 weeks"
World Health Organization quality of life instrument "WHOQOL-BREF"
Time Frame: • ""At baseline and at the end of treatment at 4 weeks""
Quality of life assessment questionnaire. A validated Arabic version was used. 26 items The scores on the scale from 1- 5 : 1 is the lowest score while 5 is the highest score. The higher score the participants get, the better QoL they have
• ""At baseline and at the end of treatment at 4 weeks""
Biodex Gait Trainer
Time Frame: • ""At baseline and at the end of treatment at 4 weeks""
A special treadmill to measure gait kinematic parameters
• ""At baseline and at the end of treatment at 4 weeks""

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Maram A Mahmoud, MSc, Cairo University Hospitals
  • Study Chair: Nahed A Salem, PhD, Cairo University
  • Study Chair: Ebtesam M Fahmy, PhD, Cairo University
  • Study Director: Amina M Awad, PhD, Cairo University
  • Study Director: Asma A Salem, PhD, Faculty of Physical Therapy Suez University
  • Study Director: Sarah Heneidy, PhD, Cairo University
  • Study Chair: Rania M Tawfik, PhD, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2024

Primary Completion (Actual)

August 30, 2024

Study Completion (Actual)

October 28, 2024

Study Registration Dates

First Submitted

October 31, 2024

First Submitted That Met QC Criteria

November 3, 2024

First Posted (Estimated)

November 5, 2024

Study Record Updates

Last Update Posted (Estimated)

November 5, 2024

Last Update Submitted That Met QC Criteria

November 3, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.TREC / 012 / 003990

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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