Clinical trial NCT06382454: Upper Extremity Robot-Assisted Therapy in Stroke Patients
Official title: Investigation of The Effect of Upper Extremity Robot-Assisted Therapy on Upper Extremity Performance in Stroke Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Upper Extremity
Keywords: Stroke
Robot-Assisted Therapies
Upper Extremity
Exoskeleton Robot
Motor Performance
Lead sponsor: Hacettepe University
Sponsor class: OTHER
Collaborators: name: Interact Medical Technologies Inc.
First posted: 2024-04-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Upper extremity hemiparesis is one of the most common symptoms after stroke. Robot-assisted therapies have been used as an approach to rehabilitation of upper extremity hemiplegia in recent years. Robot-assisted therapy is an approach to post-stroke rehabilitation that uses robotic devices to provide motor or task-oriented training to patients. When the literature is examined, there are studies showing that robot-assisted therapies are similar or superior to conventional methods. In order to provide the most effective rehabilitation approach in upper extremity robots, it is suggested that it may be more accurate to consider the robotic device as a training platform consisting of various therapeutic techniques and principles, not as a tool alone. A robotic system will be used to overcome the disadvantages of the existing robotic systems in the literature such as not providing support to the patient at the time of need, not providing fluidity in shoulder movements by not taking into account the scapulohumeral rhythm in upper extremity movements, long installation times, and ignoring task-oriented training. The system to be used is a self-aligning exoskeleton system for robot-assisted upper extremity rehabilitation. The system provides safe and versatile rehabilitation at increasing intensity and also allows for objective assessments. The aim of this clinical study was to evaluate the efficacy of robot-assisted upper limb rehabilitation in stroke patients.


Eligibility criteria: Inclusion Criteria:

* Spasticity of the upper extremity muscles is 2 or less according to the Modified Ashworth Scale
* Stroke patients with a Mini Mental State Examination score of 24 and above will be included in the study

Exclusion Criteria:

* Have a neurological disease other than stroke that may affect upper extremity movements
* Surgery or botox application for upper extremity spasticity in the last 6 months
* History of upper extremity fracture or surgery
* Attending another rehabilitation program
* Individuals who do not agree to participate in the study and do not give written informed consent will be excluded from the study.

Primary outcomes:
measure: Modified Ashworth Scale
timeFrame: 5 minutes
measure: Fugl-Meyer Assessment Upper Extremity
timeFrame: 15 minutes
measure: Action Research Arm Test
timeFrame: 15 minutes
measure: Box and Block Test
timeFrame: 1 minutes
measure: Nine Hole Peg Test
timeFrame: 10 minutes
Secondary outcomes:
measure: ACTIVLIM
timeFrame: 5 minutes
measure: ABILHAND Assessment
timeFrame: 5 minutes
measure: Stroke Impact Scale
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University, Faculty of Physical Therapy and Rehabilitation
state: Altındağ, Ankara
Study officials:
affiliation: Hacettepe University
name: Muhammed Kılınç, Prof.
role: STUDY_DIRECTOR
References: