TENS and Spasticity in Stroke Patients

January 13, 2023 updated by: Riphah International University

Effects of Transcutaneous Electrical Nerve Stimulation on Upper Limb Spasticity, Strength and Functional Status in Stroke Patients

study aims to evaluate the efficacy of high and low frequency TENS on spasticity, strength and functional status in stroke patients. It may provide further knowledge concerning the use of TENS for motor impairments in stroke patients and may clarify ambiguities to some extent.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Despite the positive effects of electrical stimulation proved on motor impairments of affected limb, the evidence is still not conclusive. There still remains a question mark regarding the effectiveness and optimal stimulation parameters of TENS. there has been conflict regarding the TENS parameters (frequency, duration, intensity) among different studies. To date TENS parameters used in different studies to reduce spasticity range from frequency of 1.7-100 Hz, duration from 15-60 minutes and sessions from 1-30. The use of different parameters may account for the contradictory results related to effectiveness of TENS.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Larkana, Sindh, Pakistan
        • Chandka Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Both male and female aged 40-70 years
  • Middle cerebral artery (MCA) stroke
  • 6 months after stroke
  • Mini-mental state examination (MMSE)more than 24
  • Modified Ashworth scale score between1 and 2

Exclusion Criteria:

  • Patients with multiple sclerosis, spinal cord injury or with other pre-existing neurological disorders.
  • Patients with orthopedic condition affecting upper extremity
  • Patients with contraindication to TENS, like skin damaged etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High Frequency TENS
high frequency TENS (100 Hz, 200 us) over the muscle belly of triceps and wrist extensors, for 5 days per week over 8 weeks combined with task related training.
Device: High Frequency TENS
30 minutes of high frequency TENS (100 Hz, 200 us) over the muscle belly of triceps and wrist extensors, for 5 days per week over 8 weeks combined with task related training.
Experimental: Low Frequency TENS
low frequency TENS (20 Hz, 0.2 us) over the muscle belly of triceps and wrist extensors, for 5 days per week over 8 weeks with task related training.
Device: Low Frequency TENS
30 minutes of low frequency TENS (20 Hz, 0.2 us) over the muscle belly of triceps and wrist extensors, for 5 days per week over 8 weeks. And combined with 30 minutes of TRT.
Active Comparator: Task Related Training
postural control, shoulder mobilization, weight bearing exercises, functional activities that will comprise of simple tasks to more advanced movement patterns
Other: Task Related Training

Each session of TRT would include:

1. postural control, 2. shoulder mobilization, 3. weight bearing exercises 4. Functional activities that will comprise of simple tasks to more advanced movement patterns as follows:

  • Reaching activities

    1. Forward supported reach with cane on tabletop
    2. Reaching against gravity
    3. Reaching overhead with active wrist/hand movements
    4. Dynamic reaching to target e.g. catch a ball

  • Grasping, holding and release

    1. Grasp, hold and release objects with gravity minimized
    2. Pick up and move/release small objects on table
    3. Pick up and move/release large objects without proximal support
    4. Incorporate pinch grips in hold and release including stacking, lifting and overhead activity

  • Upper limb ADL

    1. Brushing hair, putting on scarf
    2. Opening bottles, turning off water tap
    3. Writing, drawing
    4. Folding of towels, hanging towels and setting table
    5. Self-feeding

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Ashworth Scale (MAS)
Time Frame: 8 weeks
Modified Ashworth Scale (MAS) is a subjective method used clinically to measure spasticity. It has verified validity to test spasticity. MAS is six point scale (0,1,2,3,4,5) with a 0 indicating no resistance and 5 indicating rigidity. It has good intra and inter-rater reliability with inter-rater reliability of r= 0.92 and intra-rater reliability at r=0.86.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Manual Muscle Testing (MMT)
Time Frame: 8 weeks
MMT is used as a clinical procedure to test the strength of muscle. During procedure the therapist observe the muscle's ability to produce movement and respond to manual resistance to assign ordinal scores. 6 point scale is used to grade the muscle strength, (0,1,2,3,4,5) where 0 indicates no perceptible muscle contraction while 5 indicates maximum force generation by muscle against maximum resistance. The MMT has well established validity relative to other measures of muscle strength.
8 weeks
Action Research Arm Test (ARAT)
Time Frame: 8 weeks
The action research arm test has been used to assess the ability of affected limb to perform activities. It consists of 19 items in which subject is asked to grasp, move and release objects of different shape and size. They are also asked to perform gross movements. Each item is scored on 4 point scale with 0 indicating no action can be performed and 3 indicating that action has been performed successfully within time. validity and reliability of ARA has been confirmed with intra-rater reliability ranging from 0.71-0.99.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Mirza Obaid Baig, MSPT(NMR), Riphah International University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2021

Primary Completion (Actual)

July 31, 2022

Study Completion (Actual)

August 31, 2022

Study Registration Dates

First Submitted

September 17, 2021

First Submitted That Met QC Criteria

September 29, 2021

First Posted (Actual)

October 12, 2021

Study Record Updates

Last Update Posted (Estimate)

January 16, 2023

Last Update Submitted That Met QC Criteria

January 13, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC01037 Komal Mazhar

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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