TENS Effect on Gait and QoL in Stroke.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-10

Study Completion Date

2024-10-28

Brief Summary

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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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Detailed Description

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinded randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

stactician

Study Groups

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Intervention arm

TENS applied to acupuncture points in addition to physical therapy program

Group Type ACTIVE_COMPARATOR

Transcutaneous electrical nerve stimulation (TENS)

Intervention Type DEVICE

TENS is applied on the acupuncture points Intervention arm

Physical Therapy program

Intervention Type OTHER

Physical therapy methods

control arm

only physical therapy program

Group Type ACTIVE_COMPARATOR

Physical Therapy program

Intervention Type OTHER

Physical therapy methods

Interventions

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Transcutaneous electrical nerve stimulation (TENS)

TENS is applied on the acupuncture points Intervention arm

Intervention Type DEVICE

Physical Therapy program

Physical therapy methods

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No