TENS and Spasticity in Stroke Patients

NCT ID: NCT05075109

Last Updated: 2023-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-26
• Study Completion Date: 2022-08-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

High Frequency TENS

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Low Frequency TENS

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Task Related Training

Intervention Type: OTHER

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

1. Forward supported reach with cane on tabletop

2. Reaching against gravity

3. Reaching overhead with active wrist/hand movements

4. Dynamic reaching to target e.g. catch a ball

• Grasping, holding and release

1. Grasp, hold and release objects with gravity minimized

2. Pick up and move/release small objects on table

3. Pick up and move/release large objects without proximal support

4. Incorporate pinch grips in hold and release including stacking, lifting and overhead activity

• Upper limb ADL

1. Brushing hair, putting on scarf

2. Opening bottles, turning off water tap

3. Writing, drawing

4. Folding of towels, hanging towels and setting table

5. Self-feeding

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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

1. Forward supported reach with cane on tabletop

2. Reaching against gravity

3. Reaching overhead with active wrist/hand movements

4. Dynamic reaching to target e.g. catch a ball

• Grasping, holding and release

1. Grasp, hold and release objects with gravity minimized

2. Pick up and move/release small objects on table

3. Pick up and move/release large objects without proximal support

4. Incorporate pinch grips in hold and release including stacking, lifting and overhead activity

• Upper limb ADL

1. Brushing hair, putting on scarf

2. Opening bottles, turning off water tap

3. Writing, drawing

4. Folding of towels, hanging towels and setting table

5. Self-feeding

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mirza Obaid Baig, MSPT(NMR)

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Chandka Medical College Hospital

Larkana, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

REC01037 Komal Mazhar

Identifier Type: -

Identifier Source: org_study_id