The Effect of Speed-based Training on Spasticity and Balance

NCT05256030 | Unknown

• 1 other identifier: E-60116787-020-168618
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

While there are many studies examining the effect of different exercises on spasticity and balance activities in individuals with stroke, no study has been found on the effect of speed-based re-learning training on spasticity and balance activities. In this study, it was aimed to investigate whether the WBV treatment protocol determined has an effect on functional capacity and respiratory functions in individuals with stroke. In this sense, our study was planned to investigate the effect of speed-based motor learning training on spasticity characteristics and balance activities in stroke patients.

Conditions

Stroke; Spasticity, Muscle; Balance; Distorted

Keywords

Stroke; Velocity; Re-learning; Spasticity; Balance

Outcome Measures

Primary Outcomes (4)

• Modified Tardieu Scale

  The scale evaluates spasticity from three different rates in order to evaluate the rate-dependent effect of spasticity. These speeds are defined as speeds V1, V2 and V3. The speed V1 represents the evaluation at the lowest speed, and V3 represents the evaluation at the highest speed. In all 3 speeds, the target joints are moved passively through the full range of motion and the range of values in which spasticity is observed is calculated by means of a goniometer.

  6 weeks

• Berg Balance Scale

  It is a scale that includes 14 instructions and is scored between 0-4 by observing the patient's performance for each instruction. While 0 points are given when the patient cannot do the activity at all, 4 points are given when the patient completes the activity independently.

  6 weeks

• Time Up and Go Test

  The person is asked to get up from the chair he is sitting in, walk 3 meters at a safe and normal pace, turn, walk back and sit back in the chair. The time it takes to complete the test is recorded in seconds.

  6 weeks

• Portable computerized kinesthetic balance device (SportKAT 550)

  The device consists of two parts, an electronic tilt sensor and a moving platform. The electronic sensor evaluates the movement of the platform during the test period and transfers the data to the connected computer. The computer screen is placed 1 meter in front of the people and at eye level to provide feedback to the people. The computer screen has a red cross indicating the movement of the platform. The evaluated person tries to keep this sign on the screen in the center for 30 seconds. At the end of the test, the device calculates a balance score. This score shows how close the person holds the platform to the reference position. At the end of the test, scores ranging from 0 to 6000 are formed.

  6 weeks

Study Arms (2)

Control-Traditional Rehabilitation Group

EXPERIMENTAL

This group will receive a 6-week neurorehabilitation program that includes stretching for spasticity inhibition, strengthening of the antagonist muscle, autogenic inhibition methods, as well as conscious-unconscious balance training and gait training, which are routinely applied in physical therapy and rehabilitation units. The treatment will be applied 5 days a week. In addition to the Bobath approach, the subjects in the study group received WBV for 20 minutes a day, 2 days a week. The frequency of the device was increased by 5 Hz every week, starting the treatment with 30 Hz. Whole body vibration application was performed on a platform (Power Plate Pro5®) that provides vertical vibration. Two different practice positions were chosen as standing and semi-squatting. In order to prevent muscle fatigue, the set consisting of 1 minute of application - 1 minute of rest in each position was applied for a total of 10 minutes with 5 repetitions

Other: Speed-based relearning training

Study-Neurodevelopmental Therapy Group

EXPERIMENTAL

Function-oriented Neurodevelopmental Therapy will be applied to the subjects included in the study and randomly assigned to the study group in different positions such as supine, prone, sitting, standing for 6 weeks, 5 sessions per week, and the goal will be to achieve the task at different speeds. Spasticity, balance and gait exercises will be started at slow speeds, at muscle level, and in the following sessions, movement speed will be increased in relation to the patient's compliance, and global balance and gait exercises will be performed.

Other: Neurodevelopmental Therapy

Interventions

Speed-based relearning training OTHER

Spasticity, balance and gait exercises will be started at slow speeds, at muscle level, and in the following sessions, movement speed will be increased in relation to the patient's compliance, and global balance and gait exercises will be performed.

Control-Traditional Rehabilitation Group

Neurodevelopmental Therapy OTHER

Neurodevelopmental Therapy

Study-Neurodevelopmental Therapy Group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Post-stroke hemiparetic-hemiplegic clinical picture
• Getting 0-3 points according to the Modified Rankin Scale
• Brunnstorm lower extremity stage≥ 2
• Getting a score of 24 or higher on the Mini Mental test
• Being clinically stable
• Having a stroke for the first time
• Single hemisphere involvement

You may not qualify if:

• Not having spasticity
• Having any neurological, psychiatric, orthopedic, unstable cardiovascular disease other than stroke

Sponsors & Collaborators

• Suleyman Demirel University: lead

Study Sites (1)

Mehmet Duray

Isparta, 32200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke; Muscle Spasticity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mehmet Duray

CONTACT

+902462113268; mehmetduray@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: February 25, 2022
• Study Start: March 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: September 1, 2022
• Last Updated: February 25, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)