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TENS Effect on Gait and QoL in Stroke.

Not Applicable
Completed
Conditions
Stroke
Registration Number
NCT06673940
Lead Sponsor
Cairo University
Brief Summary

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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
30
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Modified Ashworth scale (MAS)• "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.

World Health Organization quality of life instrument "WHOQOL-BREF"• ""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

Biodex Gait Trainer• ""At baseline and at the end of treatment at 4 weeks""

A special treadmill to measure gait kinematic parameters

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Faculty of Physical Therapy Cairo University

🇪🇬

Cairo, Giza, Egypt

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