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TENS and Spasticity in Stroke Patients

R

Riphah International University

Status

Completed

Conditions

Stroke

Treatments

Device: Low Frequency TENS
Device: High Frequency TENS
Other: Task Related Training

Study type

Interventional

Funder types

Other

Identifiers

NCT05075109
REC01037 Komal Mazhar

Details and patient eligibility

About

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.

Full 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.

Enrollment

54 patients

Sex

All

Ages

40 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

54 participants in 3 patient groups

High Frequency TENS
Experimental group
Description:
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.
Treatment:
Device: High Frequency TENS
Low Frequency TENS
Experimental group
Description:
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.
Treatment:
Device: Low Frequency TENS
Task Related Training
Active Comparator group
Description:
postural control, shoulder mobilization, weight bearing exercises, functional activities that will comprise of simple tasks to more advanced movement patterns
Treatment:
Other: Task Related Training

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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