Exoskeleton-assisted Upper Limb Rehabilitation After Stroke

Stroke Clinical Trial

Official title:

Exoskeleton-assisted Upper Limb Rehabilitation After Stroke: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04353622
• Other study ID #: 09.2019.146
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: May 15, 2019

Study information

• Verified date: October 2023
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 15, 2019
• Est. primary completion date: May 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke
• Upper Extremity Dysfunction

Intervention

Device:
• Exoskeleton robot for upper extremity
Robot-assisted Treatment Program: 10 minutes elbow flexion/extension 10 minutes forearm supination/pronation 10 minutes wrist flexion/extension 10 minutes ulnar/radial deviation Frequency: 2/week Duration: 12 sessions (6 weeks)

Other:
• Conventional physiotherapy
Ferquency: 2/week Duration: 12 sessions (6weeks) Each session: 50 minutes

Locations

Country	Name	City	State
Turkey	Marmara University Faculty of Health Sciences	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mini-Mental State Examination	Mini-Mental State Examination is used to determine the cognitive level. This scale consists of 11 items. The highest score is 30. 24 and higher scores are considered normal.	Before treatment
Primary	Fugl-Meyer Upper Extremity Assessment	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.	before treatment and at six weeks of the beginning of the treatment
Primary	Modified Ashworth Scale	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).	before treatment and at six weeks of the beginning of the treatment
Secondary	Upper Extremity Motor Activity Log	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.	before treatment and at six weeks of the beginning of the treatment
Secondary	Nottingham Extended Activities of Daily Living Scale	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.	before treatment and at six weeks of the beginning of the treatment