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Completed

NCT Number: NCT05075109

TENS and Spasticity in Stroke Patients

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chandka Medical College Hospital

Larkana, Sindh, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High Frequency TENS

Device

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.

Low frequency TENS

Device

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.

Task Related Training

Other

Each session of TRT would include:

  • 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

Primary outcomes

  1. 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

  1. Manual Muscle Testing (MMT)

    Time frame: 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.

  2. Action Research Arm Test (ARAT)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 12, 2021
Registry last updated
Jan 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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