TENS and Spasticity in Stroke Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stroke

Intervention / Treatment
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* Device: High Frequency TENS
* Device: Low Frequency TENS
* Other: Task Related Training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Frequency TENS<br>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<br>* 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.<br>|
| Experimental: Low Frequency TENS<br>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<br>* 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.<br>|
| Active Comparator: Task Related Training<br>postural control, shoulder mobilization, weight bearing exercises, functional activities that will comprise of simple tasks to more advanced movement patterns | Other: Task Related Training<br>* 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 Forward supported reach with cane on tabletop Reaching against gravity Reaching overhead with active wrist/hand movements Dynamic reaching to target e.g. catch a ball Grasping, holding and release Grasp, hold and release objects with gravity minimized Pick up and move/release small objects on table Pick up and move/release large objects without proximal support Incorporate pinch grips in hold and release including stacking, lifting and overhead activity Upper limb ADL Brushing hair, putting on scarf Opening bottles, turning off water tap Writing, drawing Folding of towels, hanging towels and setting table Self-feeding<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Ashworth Scale (MAS) | 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) | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spasticity, Upper limb, TENS