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Clinical Trials/NCT05075109
NCT05075109
Completed
Not Applicable

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

Riphah International University1 site in 1 country54 target enrollmentJune 26, 2021
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Riphah International University
Enrollment
54
Locations
1
Primary Endpoint
Modified Ashworth Scale (MAS)
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
June 26, 2021
End Date
August 31, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Manual Muscle Testing (MMT)(8 weeks)
  • Action Research Arm Test (ARAT)(8 weeks)

Study Sites (1)

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