TENS Effect on Gait and QoL in Stroke.

NCT06673940 | Completed

• 1 other identifier: P.TREC / 012 / 003990
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke; spasticity; TENS; acupuncture points; gait; quality of life

Outcome Measures

Primary Outcomes (3)

• Modified Ashworth scale (MAS)

  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"

  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

  A special treadmill to measure gait kinematic parameters

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

Study Arms (2)

Intervention arm

ACTIVE COMPARATOR

TENS applied to acupuncture points in addition to physical therapy program

Device: Transcutaneous electrical nerve stimulation (TENS); Other: Physical Therapy program

control arm

ACTIVE COMPARATOR

only physical therapy program

Other: Physical Therapy program

Interventions

Transcutaneous electrical nerve stimulation (TENS) DEVICE

TENS is applied on the acupuncture points Intervention arm

Intervention arm

Physical Therapy program OTHER

Physical therapy methods

Intervention arm; control arm

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy Cairo University

Cairo, Giza Governorate, 12654, Egypt

Location

MeSH Terms

Conditions

Stroke; Muscle Spasticity

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Maram A Mahmoud, MSc

  Cairo University

  PRINCIPAL INVESTIGATOR

• Nahed A Salem, PhD

  Cairo University

  STUDY CHAIR

• Ebtesam M Fahmy, PhD

  Cairo University

  STUDY CHAIR

• 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 DIRECTOR

• Rania M Tawfik, PhD

  Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: stactician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Physical Therapy for Neurology and Neurosurgery, Faculty of Physical Therapy, Cairo University

Model Details: Blinded randomized controlled trial

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 5, 2024
• Study Start: February 10, 2024
• Primary Completion: August 30, 2024
• Study Completion: October 28, 2024
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)