Clinical trial NCT04353622: Exoskeleton-assisted Upper Limb Rehabilitation After Stroke
Official title: Exoskeleton-assisted Upper Limb Rehabilitation After Stroke: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Upper Extremity Dysfunction
Keywords: Stroke
Upper extremity
Robotic rehabilitation
Motor function
Quality of life
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2020-04-20
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In recent studies, it has been observed that robotic devices make a positive contribution to motor recovery and the activities of daily living. However, studies about the effects of stroke rehabilitation with robotic devices are limited.

This study aimed to investigate the effect of upper extremity robotic rehabilitation on motor function and quality of life in stroke patients.

Detailed description: Stroke survivors have difficulties in participating in activities of daily living due to functional disabilities. The majority of patients after stroke need rehabilitation to gain independence in daily life as the first target. Therefore, different treatment approaches are used in stroke rehabilitation.

The use of technology in stroke rehabilitation has become very common in recent years. Robotic devices used in rehabilitation enhance the healing process by giving patients more intensive and task-oriented exercises. A lot of systematic and meta-analysis studies have shown that robot-assisted devices provide positive motor recoveries, especially in the treatment of upper extremities. However, the optimal timing, duration, and dose of robotic rehabilitation that should be applied after stroke remain uncertain.

In the light of this information, this study examines the effects of the robotic device produced for upper limb rehabilitation on daily life activities and motor function.

Eligibility criteria: Inclusion Criteria:

* Having ischemic or hemorrhagic stroke history
* Being at the age between 40 and 85
* MAS (Modified Ashworth Scale) \< 3 for upper extremity
* At least 6 months after stroke
* Participants who agree to participate in the study

Exclusion Criteria:

* Cardiovascular weakness (severe hypertension, coronary artery disease)
* Mini-Mental State Examination score \< 24
* Recurrent stroke
* Having other orthopedic and neurologic conditions that may affect upper extremity movement
* Having behavioral and cognitive problems

Primary outcomes:
measure: Fugl-Meyer Upper Extremity Assessment
timeFrame: before treatment and at six weeks of the beginning of the treatment
measure: Modified Ashworth Scale
timeFrame: before treatment and at six weeks of the beginning of the treatment
Secondary outcomes:
measure: Upper Extremity Motor Activity Log
timeFrame: before treatment and at six weeks of the beginning of the treatment
measure: Nottingham Extended Activities of Daily Living Scale
timeFrame: before treatment and at six weeks of the beginning of the treatment
Other outcomes:
measure: Mini-Mental State Examination
timeFrame: Before treatment
Locations:
city: Istanbul
country: Turkey
facility: Marmara University Faculty of Health Sciences
Study officials:
affiliation: Marmara University
name: İrem Akgün
role: PRINCIPAL_INVESTIGATOR
References: