Evaluation of Hand Strength and Spasticity in Hemiplegic Patients

NCT05662878 | Completed

• 1 other identifier: HemiHFR22
• Study Type: observational
• Target: 161
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neurological Rehabilitation; Stroke; Upper Extremity Problem

Keywords

Hemiplegia; Spasticity; Hand Grip Strength; Finger-Hand Robot

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Patient Group

Hemiplegic Patients

Other: Assessment of Hand Strength and Spasticity

Control Group

Healthy Individuals

Other: Assessment of Hand Strength and Spasticity

Interventions

Assessment of Hand Strength and Spasticity OTHER

Assessment of Hand Strength and Spasticity

Control Group; Patient Group

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

Study Sites (1)

Afyonkarahisar Health Sciences University

Afyonkarahisar, 03200, Turkey (Türkiye)

Location

Related 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.

  PMID: 32937973 BACKGROUND

• 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.

  PMID: 28664214 BACKGROUND

• 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.

  PMID: 31801402 BACKGROUND

MeSH Terms

Conditions

Stroke; Hemiplegia; Muscle Spasticity

Condition Hierarchy (Ancestors)

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

Study Officials

• Sevda ADAR, MD

  Afyonkarahisar Health Sciences University

  PRINCIPAL INVESTIGATOR

• Ali İzzet AKÇİN, MD

  Afyonkarahisar Health Sciences University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: December 23, 2022
• Study Start: October 15, 2022
• Primary Completion: February 20, 2023
• Study Completion: April 30, 2023
• Last Updated: May 9, 2023

Record last verified: 2023-05

Locations

TU (1)