TENS and Spasticity in Stroke Patients
- Conditions
- Stroke
- Interventions
- Device: Low Frequency TENSDevice: High Frequency TENSOther: Task Related Training
- Registration Number
- NCT05075109
- Lead Sponsor
- Riphah International University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low Frequency TENS 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. High Frequency TENS 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. Task Related Training Task Related Training postural control, shoulder mobilization, weight bearing exercises, functional activities that will comprise of simple tasks to more advanced movement patterns
- Primary Outcome Measures
Name Time Method Modified Ashworth Scale (MAS) 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 Outcome Measures
Name Time Method Manual Muscle Testing (MMT) 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.
Action Research Arm Test (ARAT) 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.
Trial Locations
- Locations (1)
Chandka Medical College Hospital
🇵🇰Larkana, Sindh, Pakistan