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

NCT06562530 | Active Not Recruiting

• 1 other identifier: P. T. REC/012/004855
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

high tone power therapy; spatiotemporal gait parameters; gait kinematics

Outcome Measures

Primary Outcomes (10)

• Modified Ashworth Scale (MAS)

  This scale is used to measure spasticity of Calf muscle in grades from 0 to 5.

  measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention

• Computerized electromyography (EMG) using H/M ratio

  EMG is an objective device used to measure spasticity of the Soleus muscle in percentage (%)

  measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention

• Ten-meter Walk test(10-MWT)

  This scale is used to measure walking speed in m/s * self-selected walking speed (SSWS) in (m/s). * fastest walking speed (FWS) in (m/s).

  measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention

• Time up and go test (TUG)

  This test is used to measure time taken by patient to apply sit to stand, walk a distance of 3 meters, turn and walk back to the chair in (sec.)

  measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention

• Gait velocity

  Gait Analyzer Smart Phone Application is an objective tool that assesses gait velocity (m/s).

  measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention

• cadence

  Gait Analyzer Smart Phone Application is an objective tool that assesses cadence: the number of steps per second in (steps/ s).

  measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention

• step time

  Gait Analyzer Smart Phone Application is an objective tool that assesses step time in ( msec.)

  measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention

• step time symmetry

  Gait Analyzer Smart Phone Application is an objective tool that assesses step time symmetry: the symmetry in time between affected and unaffected lower limbs in percentage (%)

  measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention

• step length

  Gait Analyzer Smart Phone Application is an objective tool that assesses step length by the inertial sensor system symmetry in meters (m).

  measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention

• step length symmetry

  Gait Analyzer Smart Phone Application is an objective tool that assesses step length symmetry: the symmetry in step length between affected and unaffected lower limbs in percentage (%)

  measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention

Secondary Outcomes (1)

• Lafayette Hand-held Dynamometer

  measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention

Study Arms (3)

The control group

ACTIVE COMPARATOR

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

Other: selected physical therapy program

The study group1

EXPERIMENTAL

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).

Device: high tone power therapy; Other: selected physical therapy program

The study group 2

EXPERIMENTAL

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).

Device: transcutaneous electrical nerve stimulation (TENS); Other: selected physical therapy program

Interventions

high tone power therapy DEVICE

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

The study group1

transcutaneous electrical nerve stimulation (TENS) DEVICE

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

The study group 2

selected physical therapy program 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 control group; The study group 2; The study group1

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Duration of illness not less than six months post-stroke (Hillis A. et al., 2006).
• Patients' age ranges from forty-five to sixty-five years (Feigin et al., 2022).
• Body mass index from (18.5 to 24.9).
• 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).
• Able to walk independently on an even surface without any assistive device (Fan and Yin, 2013).
• Patients with moderate Spasticity of the ankle joint (grade 2 and 3 According to Modified Ashworth Scale) (Hegazy et al., 2020).

You may not qualify if:

• Subjects with any other Co-existing Progressive neurological disorder (Hegazy et al., 2020).
• Unstable Cardiac condition (E.g., Acute Myocardial infarction, severe Cardiac Failure) (Teslim et al., 2013).
• Subjects with any anti-spastic Drugs (Chang et al., 2013).
• 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.
• Any previous Contracture or deformities (Hegazy et al., 2020).
• Un co-operative patients (Gupta and Chatterjee, 2019).
• Open wounds, burns, or Loss of sensation (Grevstad et al., 2016).
• Patients with metal implants (von Lewinski et al., 2009).
• Visual, auditory problems.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

faculty of physical therapy, Cairo university

Giza, Egypt

Location

MeSH Terms

Conditions

Stroke

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Eman S Fayiz, Professor

  Cairo University

  STUDY CHAIR

• Mahmoud Y El-Zanaty

  Cairo University

  STUDY CHAIR

• Sandraa M Ahmed, Professor

  Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer assistant of physical therapy for neurology and neurosurgery

Model Details: Randomized controlled trial (RCT). True experimental research design study

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 20, 2024
• Study Start: January 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)