Clinical trial NCT05662878: Evaluation of Hand Strength and Spasticity in Hemiplegic Patients
Official title: Evaluation of Hand Strength and Spasticity in Hemiplegic Patients Using Hand-Finger Robot Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurological Rehabilitation
Stroke
Upper Extremity Problem
Keywords: Hemiplegia
Spasticity
Hand Grip Strength
Finger-Hand Robot
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2022-12-23
Enrollment: 161
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Neurophysiological Evaluation
timeFrame: 2022.12-2023.1
measure: Muscle Power Assessment (MRC Scale)
timeFrame: 2022.12-2023.1
measure: Spasticity Evaluation
timeFrame: 2022.12-2023.1
measure: The Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
timeFrame: 2022.12-2023.1
measure: Hand and Finger Grip Strength Assessment
timeFrame: 2022.12-2023.1
measure: Assessment with Amadeo Device
timeFrame: 2022.12-2023.1
Secondary outcomes:
Other outcomes:
Locations:
city: Afyonkarahisar
country: Turkey
facility: Afyonkarahisar Health Sciences University
Study officials:
affiliation: Afyonkarahisar Health Sciences University
name: Sevda ADAR, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Afyonkarahisar Health Sciences University
name: Ali İzzet AKÇİN, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.