Evaluation of Hand Strength and Spasticity in Hemiplegic Patients

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

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

Study Overview

• Status: Completed
• Conditions: Stroke; Neurological Rehabilitation; Upper Extremity Problem
• Intervention / Treatment: Other: Assessment of Hand Strength and Spasticity

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 161

Contacts and Locations

Study Locations

• Turkey
  • Afyonkarahisar, Turkey, 03200
    • Afyonkarahisar Health Sciences University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

250 hemiplegia patients and 50 healthy controls aged between 40-85 years who applied to our clinic will be included in the study.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient Group; Hemiplegic Patients	Other: Assessment of Hand Strength and Spasticity; Assessment of Hand Strength and Spasticity
Control Group; Healthy Individuals	Other: Assessment of Hand Strength and Spasticity; Assessment of Hand Strength and Spasticity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurophysiological Evaluation	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.	2022.12-2023.1
Muscle Power Assessment (MRC Scale)	The MRC is a scale for muscle strength that ranges from 0 to 5, relative to the maximum expected for a given muscle.	2022.12-2023.1
Spasticity Evaluation	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.	2022.12-2023.1
The Fugl-Meyer Assessment for Upper Extremity (FMA-UE)	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.	2022.12-2023.1
Hand and Finger Grip Strength Assessment	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.	2022.12-2023.1
Assessment with Amadeo Device	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.	2022.12-2023.1

Collaborators and Investigators

• Sponsor: Afyonkarahisar Health Sciences University
• Investigators: Principal Investigator: Ali İzzet AKÇİN, MD, Afyonkarahisar Health Sciences University; Principal Investigator: Sevda ADAR, MD, Afyonkarahisar Health Sciences University

Publications and helpful links

General Publications

• de-la-Torre R, Ona ED, Balaguer C, Jardon A. Robot-Aided Systems for Improving the Assessment of Upper Limb Spasticity: A Systematic Review. Sensors (Basel). 2020 Sep 14;20(18):5251. doi: 10.3390/s20185251.
• Dehem S, Gilliaux M, Lejeune T, Detrembleur C, Galinski D, Sapin J, Vanderwegen M, Stoquart G. Assessment of upper limb spasticity in stroke patients using the robotic device REAplan. J Rehabil Med. 2017 Jul 7;49(7):565-571. doi: 10.2340/16501977-2248.
• Luo Z, Lo WLA, Bian R, Wong S, Li L. Advanced quantitative estimation methods for spasticity: a literature review. J Int Med Res. 2020 Mar;48(3):300060519888425. doi: 10.1177/0300060519888425. Epub 2019 Dec 4.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2022
• Primary Completion (Actual): February 20, 2023
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: December 15, 2022
• First Submitted That Met QC Criteria: December 15, 2022
• First Posted (Actual): December 23, 2022

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 7, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Spasticity; Hand Grip Strength; Hemiplegia; Finger-Hand Robot
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Muscle Spasticity
• Other Study ID Numbers: HemiHFR22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No