NCT05662878|Completed
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Sponsor study identifier
observational
161
1 country
1
Study Start
October 15, 2022
Actual (reported)Primary Completion
February 20, 2023
Actual (reported)Study Completion
April 30, 2023
Actual (reported)The aim in this study is to evaluate spasticity and hand grip strength with a finger hand robot in the Turkish population.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 30, 2023
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 15, 2022
Actual (reported)December 15, 2022
Actual (reported)December 23, 2022
Actual (reported)February 20, 2023
Actual (reported)April 30, 2023
Actual (reported)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
Hemiplegic Patients
Healthy Individuals
Assessment of Hand Strength and Spasticity
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
250 hemiplegia patients and 50 healthy controls aged between 40-85 years who applied to our clinic will be included in the study.
Afyonkarahisar Health Sciences University
Afyonkarahisar, 03200, Turkey (Türkiye)
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.
Sevda ADAR, MD
Afyonkarahisar Health Sciences University
Ali İzzet AKÇİN, MD
Afyonkarahisar Health Sciences University
161 participants (actual enrollment reported by the registry).
First Submitted
December 15, 2022
First Posted
December 23, 2022
Study Start
October 15, 2022
Actual (reported)Evaluation of the Effect of Repetitive Peripheral Magnetic Stimulation on Upper Extremity Spasticity After Stroke
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
Contact the study team to confirm eligibility.
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.
Primary Completion
February 20, 2023
Actual (reported)Study Completion
April 30, 2023
Actual (reported)Last Updated
May 9, 2023
Record last verified: 2023-05
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Source: ClinicalTrials.gov.
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