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CompletedNCT05662878Updated May 9, 2023

Evaluation of Hand Strength and Spasticity in Hemiplegic Patients

An observational study in Neurological Rehabilitation, Stroke and Upper Extremity Problem, sponsored by Afyonkarahisar Health Sciences University. Completed at 1 site in Turkey. Open to participants aged 40 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-09.

Sponsored by Afyonkarahisar Health Sciences University · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
161
Ages
40 Years to 85 Years
Sex
All
01

Study summary

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

Read the 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.

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Conditions studied

  • Neurological Rehabilitation
  • Stroke
  • Upper Extremity Problem

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Keywords

  • Hemiplegia
  • Spasticity
  • Hand Grip Strength
  • Finger-Hand Robot
03

In context

Muscle Spasticity

704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.

This study's enrollment of 161 is above the median of 60 across 162 observational studies indexed under Muscle Spasticity.

Browse Muscle Spasticity studies →

Lead sponsor

Afyonkarahisar Health Sciences University is the lead sponsor of 107 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 85 Years
Sexes eligible
All
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Uncooperative Patient
  • Having a skin ulcer on the hand,
  • Patients with contractures of the hand fingers will be excluded.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
161 participants (actual)
Patient registry
No

Groups and cohorts

  • Patient Group

    Hemiplegic Patients

    Other: Assessment of Hand Strength and Spasticity

  • Control Group

    Healthy Individuals

    Other: Assessment of Hand Strength and Spasticity

Interventions

  • OtherAssessment of Hand Strength and Spasticity

    Assessment of Hand Strength and Spasticity

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2022.12-2023.1

  2. 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.

    Time frame: 2022.12-2023.1

  3. 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.

    Time frame: 2022.12-2023.1

  4. 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.

    Time frame: 2022.12-2023.1

  5. 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.

    Time frame: 2022.12-2023.1

  6. 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.

    Time frame: 2022.12-2023.1

07

Study locations

1 site
  • Afyonkarahisar Health Sciences University
    Afyonkarahisar, 03200, Turkey
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References and documents

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. PubMed 32937973 ↗
  • 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. PubMed 28664214 ↗
  • 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. PubMed 31801402 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05662878
Lead sponsor
Afyonkarahisar Health Sciences University
Responsible party
Sevda Adar (Principal Investigator, Afyonkarahisar Health Sciences University) — Principal investigator
First posted
Dec 23, 2022
Start date
Oct 15, 2022
Primary completion
Feb 20, 2023
Completion
Apr 30, 2023
Last update
May 9, 2023

Study contacts

Sevda ADAR, MD
principal investigator · Afyonkarahisar Health Sciences University
Ali İzzet AKÇİN, MD
principal investigator · Afyonkarahisar Health Sciences University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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