Evaluation of Hand Strength and Spasticity in Hemiplegic Patients

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05662878
• Other study ID #: HemiHFR22
• Status: Completed
• Start date: October 15, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: May 2023
• Source: Afyonkarahisar Health Sciences University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: April 30, 2023
• Est. primary completion date: February 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Spasticity
• Neurological Rehabilitation
• Stroke
• Upper Extremity Problem

Intervention

Other:
• Assessment of Hand Strength and Spasticity
Assessment of Hand Strength and Spasticity

Locations

Country	Name	City	State
Turkey	Afyonkarahisar Health Sciences University	Afyonkarahisar

Sponsors (1)

Lead Sponsor	Collaborator
Afyonkarahisar Health Sciences University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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