NCT04353622

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 20, 2020

Completed
Last Updated

October 19, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

February 21, 2020

Last Update Submit

October 18, 2023

Conditions

StrokeUpper Extremity Dysfunction

Keywords

StrokeUpper extremityRobotic rehabilitationMotor functionQuality of life

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Upper Extremity Motor Activity Log

    before treatment and at six weeks of the beginning of the treatment

  • Nottingham Extended Activities of Daily Living Scale

    before treatment and at six weeks of the beginning of the treatment

Other Outcomes (1)

  • Mini-Mental State Examination

    Before treatment

Study Arms (2)

Robot-assisted Treatment

ACTIVE COMPARATOR

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

Device: Exoskeleton robot for upper extremity

Conventional Physiotherapy

ACTIVE COMPARATOR

Conventional physiotherapy program included neurophysiological approaches.

Other: Conventional physiotherapy

Interventions

Exoskeleton robot for upper extremityDEVICE

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)

Robot-assisted Treatment
Conventional physiotherapyOTHER

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

Conventional Physiotherapy

Eligibility Criteria

Age40 Years - 85 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University Faculty of Health Sciences

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • İrem Akgün

    Marmara University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

February 21, 2020

First Posted

April 20, 2020

Study Start

February 1, 2019

Primary Completion

May 15, 2019

Study Completion

May 15, 2019

Last Updated

October 19, 2023

Record last verified: 2023-10

Locations

TU(1)