Skip to content

Exoskeleton-assisted Upper Limb Rehabilitation After Stroke

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04353622
Enrollment
24
Registered
2020-04-20
Start date
2019-02-01
Completion date
2019-05-15
Last updated
2023-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke, Upper Extremity Dysfunction

Keywords

Stroke, Upper extremity, Robotic rehabilitation, Motor function, Quality of life

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.

Interventions

DEVICEExoskeleton 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)

OTHERConventional physiotherapy

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

Sponsors

Marmara University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Fugl-Meyer Upper Extremity Assessmentbefore treatment and at six weeks of the beginning of the treatmentFugl-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.
Modified Ashworth Scalebefore treatment and at six weeks of the beginning of the treatmentModified 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

MeasureTime frameDescription
Upper Extremity Motor Activity Logbefore treatment and at six weeks of the beginning of the treatmentUpper 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.
Nottingham Extended Activities of Daily Living Scalebefore treatment and at six weeks of the beginning of the treatmentNottingham 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

MeasureTime frameDescription
Mini-Mental State ExaminationBefore treatmentMini-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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026