TENS and Spasticity in Stroke Patients

Sponsor

Riphah International University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05075109

Collaborator

(none)

Enrollment

Location

Arms

14.2

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Device: High Frequency TENS Device: Low Frequency TENS Other: Task Related Training	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 26, 2021

Anticipated Primary Completion Date :

Jul 31, 2022

Anticipated Study Completion Date :

Aug 31, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: High Frequency TENS

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

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.

Experimental: Low Frequency TENS

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

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.

Active Comparator: Task Related Training

postural control, shoulder mobilization, weight bearing exercises, functional activities that will comprise of simple tasks to more advanced movement patterns

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chandka Medical College Hospital	Larkana	Sindh	Pakistan

Sponsors and Collaborators

Riphah International University

Investigators

Principal Investigator: Mirza Obaid Baig, MSPT(NMR), Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Riphah International University

ClinicalTrials.gov Identifier:

NCT05075109

Other Study ID Numbers:

REC01037 Komal Mazhar

First Posted:

Oct 12, 2021

Last Update Posted:

Oct 12, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Riphah International University

Spasticity

Upper limb

TENS

Additional relevant MeSH terms:

Muscle Spasticity

Stroke

Study Results

No Results Posted as of Oct 12, 2021