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NCT Number: NCT04353622

Exoskeleton-assisted Upper Limb Rehabilitation After Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Upper Extremity Dysfunction Vascular Diseases

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University Faculty of Health Sciences

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exoskeleton robot for upper extremity

Device

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)

Conventional Physiotherapy

Other

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

Primary outcomes

  1. Fugl-Meyer Upper Extremity Assessment

    Time frame: 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.

  2. Modified Ashworth Scale

    Time frame: 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).

Secondary outcomes

  1. Upper Extremity Motor Activity Log

    Time frame: 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.

  2. Nottingham Extended Activities of Daily Living Scale

    Time frame: 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.

Other outcomes

  1. Mini-Mental State Examination

    Time frame: Before treatment

    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.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 20, 2020
Registry last updated
Oct 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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