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NCT Number: NCT05662878

Evaluation of Hand Strength and Spasticity in Hemiplegic Patients

The aim in this study is to evaluate spasticity and hand grip strength with a finger hand robot in the Turkish population.

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Key information

Conditions

Neurological Rehabilitation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemiplegia Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Upper Extremity Problem Vascular Diseases

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Afyonkarahisar Health Sciences University

Afyonkarahisar, 03200, Turkey (Türkiye)

About this study

Spasticity has been defined as "irregular sensorimotor control resulting from upper motor neuron lesion manifesting as intermittent or sustained involuntary activation of muscles".

The commonly used tools in the evaluation of spasticity are subjective clinical scales, including Ashworth Scale (AS), Modified AS (MAS), Tardieu Scale (TS), Modified TS (MTS), and Tone Assessment Scale (TAS). Current scales are based on the clinician's perception of the patient assessing spasticity through their perceptions, experience, and training over the years. An objective measure of spasticity is required, and the development of robot-based systems for this purpose can help clinicians objectify their assessment.

It has been widely shown that robotic systems can be useful in the rehabilitation of adults and children with brain damage. In addition, these systems can be used to assess upper extremity function during treatment.

The aim in this study is to evaluate spasticity and hand grip strength with a finger hand robot in the Turkish population.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hemiplegic patients with sufficient cognitive and language skills to follow instructions will be included in the study.

Exclusion criteria

  • Uncooperative Patient
  • Having a skin ulcer on the hand,
  • Patients with contractures of the hand fingers will be excluded.

Treatment and study plan

Assessment of Hand Strength and Spasticity

Other

Assessment of Hand Strength and Spasticity

Primary outcomes

  1. Neurophysiological Evaluation

    Time frame: 2022.12-2023.1

    Brunnstrom Staging is a test that evaluates the motor development of hemiplegic patients. In this test, the neurophysiological recovery process of the hemiplegic patient was defined as 6 stages. According to this staging, the lowest stage; stage 1 (flask, the stage without voluntary movement), the highest stage was determined as stage 6 (stage with isolated joint movement). In Brunnstrom staging, the hand, upper extremity, and lower extremity are evaluated separately.

  2. Muscle Power Assessment (MRC Scale)

    Time frame: 2022.12-2023.1

    The MRC is a scale for muscle strength that ranges from 0 to 5, relative to the maximum expected for a given muscle.

  3. Spasticity Evaluation

    Time frame: 2022.12-2023.1

    It was planned to evaluate spasticity with the Modified Ashworth Scale (MAS). In MAS, patients are evaluated over 4 points. 0; there is no increase in muscle tone, and 4 indicates that the extremity is rigid in flexion and extension.

  4. The Fugl-Meyer Assessment for Upper Extremity (FMA-UE)

    Time frame: 2022.12-2023.1

    The Fugl-Meyer Assessment Scale was developed to quantitatively evaluate sensorimotor recovery after stroke. It is based on Brunnstrom motor recovery stages. Turkish validity and reliability study was conducted.

  5. Hand and Finger Grip Strength Assessment

    Time frame: 2022.12-2023.1

    Grip strength will be evaluated with the Jamar hydraulic hand dynamometer. Patients will be asked to squeeze with maximum force and each measurement will be made three times, and their averages will be recorded in kg. Finger grip strength will be evaluated with the "Jamar Digital Pinchmeter". Patients will be placed in the sitting position with the wrist in 90° flexion and the forearm in the neutral position. Measurements will be made bilaterally in three different positions as lateral, palmar and fingertip grips. Patients will be asked to squeeze with maximum force and each measurement will be made three times, and their averages will be recorded in kg. The dynamometer has a dual scale readout which displays isometric grip force from 0-90 kg. Higher scores means better grip strength.

  6. Assessment with Amadeo Device

    Time frame: 2022.12-2023.1

    Amadeo (Tyromotion, Graz, Austria) is an end-effector device designed for the hand and is one of the very few options currently available on the commercial market. It is a device that is attached to the forearm with its groove-shaped structure and to the fingers with the support of magnets using bandages. The device performs flexion and extension movements of the fingers. It moves the fingers of the patients in the patterns defined in the software of the device. It provides training with passive, assistive and active movements that are ideal for use in all phases of neurological rehabilitation. It was planned to measure finger ROM, muscle strength and spasticity with Amadeo device.

Sponsors and collaborators

Lead sponsor

Afyonkarahisar Health Sciences University

Other

Registry information

Official study title

Evaluation of Hand Strength and Spasticity in Hemiplegic Patients Using Hand-Finger Robot Device

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 23, 2022
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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