Clinical trial NCT06673940: TENS Effect on Gait and QoL in Stroke.
Official title: Effect of Transcutaneous Electrical Nerve Stimulation Applied to Acupuncture Points on Gait and Quality of Life in Stroke Patients: a Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
spasticity
TENS
acupuncture points
gait
quality of life
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Blinded randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Modified Ashworth scale (MAS)
timeFrame: • "At baseline and at the end of treatment at 4 weeks"
measure: World Health Organization quality of life instrument "WHOQOL-BREF"
timeFrame: • ""At baseline and at the end of treatment at 4 weeks""
measure: Biodex Gait Trainer
timeFrame: • ""At baseline and at the end of treatment at 4 weeks""
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy Cairo University
state: Giza
Study officials:
affiliation: Cairo University Hospitals
name: Maram A Mahmoud, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Nahed A Salem, PhD
role: STUDY_CHAIR
affiliation: Cairo University
name: Ebtesam M Fahmy, PhD
role: STUDY_CHAIR
affiliation: Cairo University
name: Amina M Awad, PhD
role: STUDY_DIRECTOR
affiliation: Faculty of Physical Therapy Suez University
name: Asma A Salem, PhD
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Sarah Heneidy, PhD
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Rania M Tawfik, PhD
role: STUDY_CHAIR
References: