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Completed

NCT Number: NCT06673940

TENS Effect on Gait and QoL in Stroke.

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

45 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy Cairo University

Cairo, Giza Governorate, 12654, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcutaneous Electrical Nerve Stimulation (TENS)

Device

TENS is applied on the acupuncture points Intervention arm

physical therapy program

Other

Physical therapy methods

Primary outcomes

  1. 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.

  2. 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

  3. Biodex Gait Trainer

    Time frame: • ""At baseline and at the end of treatment at 4 weeks""

    A special treadmill to measure gait kinematic parameters

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 5, 2024
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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