TENS and Spasticity in Stroke Patients

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05075109
• Other study ID #: REC01037 Komal Mazhar
• Status: Completed
• Phase: N/A
• Start date: June 26, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: January 2023
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: August 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Spasticity
• Stroke

Intervention

Device:
• High Frequency TENS
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
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.

Other:
• Task Related Training
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

Locations

Country	Name	City	State
Pakistan	Chandka Medical College Hospital	Larkana	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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