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TENS and Spasticity in Stroke Patients

Not Applicable
Completed
Conditions
Stroke
Interventions
Device: Low Frequency TENS
Device: High Frequency TENS
Other: 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
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
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Low Frequency TENSLow Frequency TENSlow 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 TENSHigh Frequency TENShigh 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 TrainingTask Related Trainingpostural control, shoulder mobilization, weight bearing exercises, functional activities that will comprise of simple tasks to more advanced movement patterns
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
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

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