Effects of Inclusion of an Exoskeletal Device With Bio-feedback on the Motor Function Treatment of Upper Extremity in Chronic Stroke Patients

Sponsor
Marmara University (Other)
Overall Status
Completed
CT.gov ID
NCT04353622
Collaborator
(none)
24
1
2
3.4
7.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Exoskeleton robot for upper extremity
  • Other: Conventional physiotherapy
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Inclusion of an Exoskeletal Device With Bio-feedback on the Motor Function Treatment of Upper Extremity in Chronic Stroke Patients: A Randomized Controlled Trial
Actual Study Start Date :
Feb 1, 2019
Actual Primary Completion Date :
May 15, 2019
Actual Study Completion Date :
May 15, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Robot-assisted Treatment

Rehabilitation protocol was applied with robotic device (HOUSTONBIONİCS ExoRehab UE1).

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)

Active Comparator: Conventional Physiotherapy

Conventional physiotherapy program included neurophysiological approaches.

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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).

Secondary Outcome Measures

  1. 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.

  2. 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.

Other Outcome Measures

  1. Mini-Mental State Examination [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 85 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Marmara University Faculty of Health Sciences Istanbul Turkey

Sponsors and Collaborators

  • Marmara University

Investigators

  • Principal Investigator: İrem Akgün, Marmara University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
iremakgun, Physiotherapist, Marmara University
ClinicalTrials.gov Identifier:
NCT04353622
Other Study ID Numbers:
  • 09.2019.146
First Posted:
Apr 20, 2020
Last Update Posted:
Nov 20, 2020
Last Verified:
Nov 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by iremakgun, Physiotherapist, Marmara University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 20, 2020