Exoskeleton-assisted Upper Limb Rehabilitation After Stroke

Not Applicable

Completed

• Conditions: Stroke; Upper Extremity Dysfunction
• Interventions: Device: Exoskeleton robot for upper extremity; Other: Conventional physiotherapy

• Registration Number: NCT04353622
• Lead Sponsor: Marmara University

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.

Study Timeline

• Study Start: 2019-02-01
• Primary Completion: 2019-05-15
• Study Completion: 2019-05-15
• Study First Submitted: 2020-02-21
• Study First Submitted QC: 2020-04-16
• Study First Posted: 2020-04-20
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robot-assisted Treatment	Exoskeleton robot for upper extremity	Rehabilitation protocol was applied with robotic device (HOUSTONBIONİCS ExoRehab UE1).
Conventional Physiotherapy	Conventional physiotherapy	Conventional physiotherapy program included neurophysiological approaches.

Primary Outcome Measures

Name	Time	Method
Modified Ashworth Scale	before treatment and at six weeks of the beginning of the treatment	Modified Ashworth Scale is used for measuring the spasticity of upper extremity skeletal muscle. The Modified Ashworth Scale (MAS) is scored from 0 to 5 to measure the resistance encountered when performing passive muscle stretching. The lowest score is 0 (no spasticity) and the highest score is 5 (severe spasticity).
Fugl-Meyer Upper Extremity Assessment	before treatment and at six weeks of the beginning of the treatment	Fugl-Meyer Upper Extremity Assessment is an index to assess physical performance in individuals who had a stroke. This index consists of 33 items. Each item scored between 0 and 2. The highest score for the upper extremity is 66.

Secondary Outcome Measures

Name	Time	Method
Nottingham Extended Activities of Daily Living Scale	before treatment and at six weeks of the beginning of the treatment	Nottingham Extended Activities of Daily Living Scale is designed for stroke patients but can be also used for other diseases. The scale has 22 items divided into 4 areas of daily life. These areas are mobility, kitchen, domestic and leisure activities. Each item scored between 0 and 3. The highest score of scale is 66.
Upper Extremity Motor Activity Log	before treatment and at six weeks of the beginning of the treatment	Upper Extremity Motor Activity Log consists of two subscales (amount of use and quality of movement) that determine how often the patient uses the affected side in daily life activities and how successful this activity is. Items on each scale are scored between 0 and 5.

Trial Locations

Locations (1)

Marmara University Faculty of Health Sciences; 🇹🇷 Istanbul, Turkey