Effects of Robot-Assisted Upper Extremity Training on Cognitive and Physical Functions After Stroke

NCT04335422 | Completed

• 1 other identifier: 04-313-19
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke is a main cause of disability worldwide. It is characterized by motor and cognitive impairments leading to activity limitations and participation restrictions. Despite improvement in mortality and morbidity following stroke, stroke survivors need access to effective rehabilitation services. Management approach for stroke survivors is classical physical and rehabilitation medicine (PRM) interventions. Nowadays, with the advancement of technology, robotic rehabilitation systems have taken its place among the classical physical and rehabilitation medicine applications. Robotic systems for upper and lower extremity help to improve neuroplasticity by repetitive task-specific activities. Upper extremity robotic systems can be either exoskeleton or end-effector according to their mechanical designs. Exoskeleton robotic systems attach to both proximal and distal segments of the upper extremity (shoulder, elbow, forearm, wrist, fingers) and provide antigravity weight support allowing actuated axes of movements of the upper extremity joints. The system allows the reinforcement and facilitation of movements by means of visual feedback with a 3-dimensional virtual environment in which the patient is asked to perform various tasks by playing computer games. It is reported that robotic therapy can be used complementary to other rehabilitation methods. The neurophysiological effects of robotic therapy were shown to act in the brain, particularly on the primary motor cortex, putamen and capsula interna. The effect on motor recovery was associated with common, synchronous activity involving the corticospinal system. It has been reported by a recent Cochrane review that robot-assisted arm training improves arm function, arm muscle strength and activities of daily living in stroke survivors. A few studies have also reported positive effects on cognitive abilities. However, there are no controlled studies in the literature investigating the effects of robot-assisted upper limb training on cognitive functions following stroke. The aim of this study was to investigate the effects of robot-assisted upper extremity training, applied in addition to the classical PRM program, on cognitive and physical functions after stroke. Primary aim is to investigate the effects on cognitive functions whereas secondary aim is to investigate the effects on upper extremity motor functions and activities of daily living. The investigators hypothesized that adjunctive robotic upper extremity training in addition to classical PRM program would result in better cognitive and physical outcomes compared with the classical PRM program only.

Conditions

Stroke

Keywords

stroke; robotic; upper extremity; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Cognitive function

  Cognitive functions will be assessed by "Montreal Cognitive Assessment Scale (MoCA) " which evaluates visuospatial/executive functions, naming, memory, attention, language, abstraction and delayed recall. Total score ranges between 0 and 30. High scores are associated with better clinical outcomes.

  change from baseline at 6 weeks and at 18 weeks

Secondary Outcomes (4)

• Upper extremity motor functions

  change from baseline at 6 weeks and at 18 weeks

• Hand dexterity

  change from baseline at 6 weeks and at 18 weeks

• Upper extremity function

  change from baseline at 6 weeks and at 18 weeks

• Activities of Daily Living

  change from baseline at 6 weeks and at 18 weeks

Study Arms (2)

Robotic group

EXPERIMENTAL

Robotic group will receive both routine physical and rehabilitation medicine program and additional upper extremity robot-assisted training by Armeo Spring. Routine physical and rehabilitation medicine program, including physical therapy and exercises, walking and balance training, and occupational therapy to improve activities of daily living will last nearly 2 hours/day and robotic therapy one hour/day. Routine PRM program and robotic therapy will be given through 6 weeks, 5 days a week (A total of 30 sessions of routine PRM program plus robotic therapy).

Device: Robotic group (Upper extremity robot-assisted training plus routine physical and rehabilitation medicine program); Behavioral: Control group (routine physical and rehabilitation medicine program)

Control group

ACTIVE COMPARATOR

Control group will receive only routine physical and rehabilitation medicine program. Routine physical and rehabilitation medicine program, including physical therapy and exercises, walking and balance training, and occupational therapy to improve activities of daily living will last nearly 2 hours/day and will be given through 6 weeks, 5 days a week (A total of 30 sessions of routine PRM program only).

Behavioral: Control group (routine physical and rehabilitation medicine program)

Interventions

Robotic group (Upper extremity robot-assisted training plus routine physical and rehabilitation medicine program) DEVICE

Upper extremity robot-assisted training will include facilitated shoulder flexion-extension, internal-external rotation, abduction-adduction, elbow flexion-extension, forearm supination-pronation, wrist flexion-extension, ulnar-radial deviation, hand finger flexion-extension movements by means of visual feedback with a 3-dimensional virtual environment in which the patient is asked to perform various tasks such as object reaching, grasping, holding, dropping activities by playing computer games. Routine physical and rehabilitation medicine program including physical therapy and exercises, walking and balance training, and occupational therapy to improve daily living activities will be given.

Robotic group

Control group (routine physical and rehabilitation medicine program) BEHAVIORAL

Routine physical and rehabilitation medicine program including physical therapy and exercises, walking and balance training, and occupational therapy to improve daily living activities will be given.

Control group; Robotic group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients within the age range of 18-80 years
• Patients with subacute stroke (post-stroke duration 1 month - 1 year)
• Patients who have cognitive deficits and who can understand the commands to adapt to robotic training (MMSE ≤ 26)
• Patients with first stroke attack
• Patients who have never received robotic rehabilitation therapy
• Patients with upper extremity (UE) Brunnstrom Stage III and above
• Patients with a spasticity level below 3 (MAS 1-5 assessment system) according to the modified Ashworth Scale (MAS) in the affected upper extremity
• Patients who agreed to participate in the study and signed the informed consent form

You may not qualify if:

• Patients who cannot understand commands or give informed consent
• Patients without cognitive deficit (MMSE \> 26)
• Patients with aphasia
• Patients who do not have sitting balance
• Patients with unilateral neglect
• Patients with unstable systemic medical diseases that may prevent the patient to receive robotic training sessions
• Patients with psychiatric disorders
• Patients with posterior cerebral artery infarction and subarachnoid hemorrhage
• Patients with impaired vision that may affect robotic training
• Patients with a peripheral nerve injury or musculoskeletal disease of the affected upper extremity
• Patients who have pain in the affected upper extremity such that this pain might impede the patient to adapt to robotic training
• Patients with involuntary abnormal movements (e.g. dystonia)

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University

Ankara, 06230, Turkey (Türkiye)

Location

Related Links

• reference

MeSH Terms

Conditions

Stroke

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Physşcal Medicine and Rehabilitation

Model Details: Prospective randomized single blind controlled study

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 6, 2020
• Study Start: September 1, 2019
• Primary Completion: June 30, 2022
• Study Completion: July 29, 2022
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)