Effect of High Tone Power Therapy on Spasticity and Gait Kinematics in Stroke Patients

NCT ID: NCT06562530

Last Updated: 2024-08-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2024-12-31

Brief Summary

This study aims to compare between High tone power therapy (modulated frequency current) and Transcutaneous electrical nerve stimulation (fixed frequency current) on spasticity and selected kinematic gait parameters in stroke patients.

Detailed Description

Stroke is a neurological deficit attributed to an acute focal injury of the central nervous system (CNS) by a vascular cause . Stroke is one of the leading causes of disability and mortality in the globe, stroke occurs when blood flow to the brain is restricted due to a blocked or ruptured artery; the cerebral energy supply is interrupted, resulting in tissue destruction and widespread neuronal, cognitive impairments, and psychological morbidity .

Stroke is the second major cause of death and disability worldwide with over 13 million new cases annually . Stroke has been described as a major source of both mortality and global disability . Approximately 795,000 people experience stroke annually, and 60% (or 465,000) of them need rehabilitation .

Spasticity is a symptom of stroke, brain and spinal cord damage, multiple sclerosis, cerebral palsy, and other neurological illnesses that cause paralysis . The most common spastic pattern in the lower limbs is adduction and extension of the knee with an Equinovarus foot . This impacts gait patterns and daily functioning activities .

Treatment modalities for the management of spasticity include Stretching, splinting, Neuromuscular electrical stimulation (NMES), extracorporeal shock wave therapy, transcranial and spinal cord magnetic stimulation, Surgical treatment, neurectomy, rhizotomy, and myelotomy; also, many drugs used for treating spasticity oral drugs like Baclofen, Tizanidine, and injectable medications like Phenol/alcohol and Botulinum 2 toxin .

Transcutaneous electrical nerve stimulation (TENS) stimulates large diameter mechano-sensitive nerve fibers in the skin it's a non-invasive treatment that has been reported to affect pain control and sensory stimulation which is commonly used in the treatment of chronic and acute pain with possible mechanisms of action including segmental inhibition, the release of endogenous opioids, counter-irritation, nerve conduction block, increase muscle power and movement function .

High-tone power therapy (HTT) is a unique characteristic of electrotherapy. It uses intermediate frequency, metal-compatible alternating current whose frequency oscillates between approximately 4000 Hz and 33000 Hz, and intensity is adjusted, unlike traditional electrotherapies as transcutaneous electrical nerve stimulation (TENS). Its main effects are introducing energy into the body to activate cells, producing an oscillation or vibration in the cells and tissues to promote metabolism, scattering the mediators of pain and inflammation leading to pain relief, and normalizing cell metabolism and nerve regeneration ).

The effective management of spasticity continues to pose challenges to physiotherapy management, there appears to be a dearth of adequate information on high tone power therapy in the management of spasticity; There are several physiotherapy approaches for managing spasticity but there is a lack of evidence to show which is most effective .

Statement of the problem:

This study will answer the following question: Is there any difference between the effect of high-tone power therapy (modulated frequency current) versus transcutaneous electrical nerve stimulation (fixed frequency current) on spasticity and selected kinematic gait parameters in stroke patients?

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

The control group

15 patients: receiving 36 sessions of selected physical therapy program for 1 hour 3 times per week for 3 months.

Group Type: ACTIVE_COMPARATOR

selected physical therapy program

Intervention Type: OTHER

sessions are applied for 1 hour, 3 times per week, for 3 months in form o fstretching exercise , range of motion exercises , conventional gait training progressive resistance exercises

The study group1

15 patients: receiving 36 sessions of High tone power therapy program for 30 minutes and selected physical therapy program for 30 minutes 3 times per week for 3 months (total session: 1 hour).

Group Type: EXPERIMENTAL

high tone power therapy

Intervention Type: DEVICE

sessions are applied for 30 minutes, 3 times per week, for 3 months

selected physical therapy program

Intervention Type: OTHER

sessions are applied for 1 hour, 3 times per week, for 3 months in form o fstretching exercise , range of motion exercises , conventional gait training progressive resistance exercises

The study group 2

15 patients: receiving 36 sessions of TENS program for 30 minutes and selected physical therapy program for 30 minutes 3 times per week for 3 months (total session: 1 hour).

Group Type: EXPERIMENTAL

transcutaneous electrical nerve stimulation (TENS)

Intervention Type: DEVICE

sessions are applied for 30 minutes, 3 times per week, for 3 months

selected physical therapy program

Intervention Type: OTHER

sessions are applied for 1 hour, 3 times per week, for 3 months in form o fstretching exercise , range of motion exercises , conventional gait training progressive resistance exercises

Interventions

high tone power therapy

sessions are applied for 30 minutes, 3 times per week, for 3 months

Intervention Type: DEVICE

transcutaneous electrical nerve stimulation (TENS)

sessions are applied for 30 minutes, 3 times per week, for 3 months

Intervention Type: DEVICE

selected physical therapy program

sessions are applied for 1 hour, 3 times per week, for 3 months in form o fstretching exercise , range of motion exercises , conventional gait training progressive resistance exercises

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Duration of illness not less than six months post-stroke (Hillis A. et al., 2006).

2. Patients' age ranges from forty-five to sixty-five years (Feigin et al., 2022).

3. Body mass index from (18.5 to 24.9).

4. Patients can respond to verbal instructions (Consciousness and orientation to time, place, and person) more than 13 degrees on the Glasco coma scale (Hegazy et al., 2020).

5. Able to walk independently on an even surface without any assistive device (Fan and Yin, 2013).

6. Patients with moderate Spasticity of the ankle joint (grade 2 and 3 According to Modified Ashworth Scale) (Hegazy et al., 2020).

Exclusion Criteria

1. Subjects with any other Co-existing Progressive neurological disorder (Hegazy et al., 2020).

2. Unstable Cardiac condition (E.g., Acute Myocardial infarction, severe Cardiac Failure) (Teslim et al., 2013).

3. Subjects with any anti-spastic Drugs (Chang et al., 2013).

4. Musculoskeletal disorders affecting gait kinematics such as severe arthritis, knee surgery, and total hip joint replacement, lower limb fractures less than 6 months or contractures of fixed deformity, leg length discrepancy.

5. Any previous Contracture or deformities (Hegazy et al., 2020).

6. Un co-operative patients (Gupta and Chatterjee, 2019).

7. Open wounds, burns, or Loss of sensation (Grevstad et al., 2016).

8. Patients with metal implants (von Lewinski et al., 2009).

9. Visual, auditory problems.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Jasmine Magdy Mahmoud Abd-elkhalik

lecturer assistant of physical therapy for neurology and neurosurgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eman S Fayiz, Professor

Role: STUDY_CHAIR

Cairo University

Mahmoud Y El-Zanaty

Role: STUDY_CHAIR

Cairo University

Sandraa M Ahmed, Professor

Role: STUDY_CHAIR

Cairo University

Locations

faculty of physical therapy, Cairo university

Giza, , Egypt

Countries

Egypt

Other Identifiers

P. T. REC/012/004855

Identifier Type: -

Identifier Source: org_study_id