Effects of Transcutaneous Electrical Nerve Stimulation on Upper Limb Spasticity, Strength and Functional Status in Stroke Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Modified Ashworth Scale (MAS)
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)