Effect of Robotic Therapy on Upper Extremity With Stroke

Sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05815823

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to determine how adding virtual reality assisted robotic treatment to traditional rehabilitation affects stroke patients' pain levels, functional status, and daily living activities.After conventional and robotic therapy Each patient was evaluated The Barthel Index (BI), the Fugl Meyer Assessment Upper Extremity (FMA-UE), and the Visual Analogue Scale (VAS) were used to assess the patients' pain, daily living activities, and upper extremity motor function.

Condition or Disease	Intervention/Treatment	Phase
the Effect of Virtual Reality on Stroke Rehabilitation	Other: robotic exercise therapy Other: conventional therapy	N/A

Detailed Description

Materials and Methods: The study included 40 stroke patients. Two groups of patients were created. Group I also underwent 20 sessions of upper extremity robot-assisted therapy for 4 weeks, 5 days a week, for 30 minutes per session, in addition to receiving conventional therapy (5 days a week for 4 weeks, 1 hour each day). Group II only got traditional therapy. Each patient was assessed both before and after the procedure.

The Barthel Index (BI), the Fugl Meyer Assessment Upper Extremity (FMA-UE), and the Visual Analogue Scale (VAS) were used to assess the patients' pain, daily living activities, and upper extremity motor function.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Effect of Virtual Reality Assisted Upper Extremity Robotic Therapy on Pain, Daily Living Activities and Functional Status in Patients With Stroke

Actual Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Jan 1, 2017

Actual Study Completion Date :

Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: conventional therapy 20 sessions of conventional therapy was applied for 5 days a week for 4 weeks, 1 hour a day	Other: conventional therapy streching, range of motion, strengthening, balance and walking exercise
Experimental: robot-assisted therapy 20 sessions of upper extremity robot-assisted therapy was applied for 4 weeks, 5 days a week, 30 minutes a day.	Other: robotic exercise therapy Functional exercise programs such as collecting rain in a glass, grating vegetables, goalkeeper, cleaning the stove, watering flowers, wiping windows, catching fish, and exploring landscapes were applied by robotic games to the patients Other Names: robotic exercise Other: conventional therapy streching, range of motion, strengthening, balance and walking exercise

Arm

Intervention/Treatment

Experimental: conventional therapy

20 sessions of conventional therapy was applied for 5 days a week for 4 weeks, 1 hour a day

Other: conventional therapy

streching, range of motion, strengthening, balance and walking exercise

Experimental: robot-assisted therapy

20 sessions of upper extremity robot-assisted therapy was applied for 4 weeks, 5 days a week, 30 minutes a day.

Other: robotic exercise therapy

Functional exercise programs such as collecting rain in a glass, grating vegetables, goalkeeper, cleaning the stove, watering flowers, wiping windows, catching fish, and exploring landscapes were applied by robotic games to the patients

Other Names:

robotic exercise

Other: conventional therapy

streching, range of motion, strengthening, balance and walking exercise

Outcome Measures

Primary Outcome Measures

FMA-UE scale [baseline]
FMA-UE evaluates the hemiparetic arm's mobility, including reflexes, the presence of synergies, and each of the upper limb's independent motions, including grasp. The dysmetria, coordination, and velocity of the patient are also evaluated using items on this scale. It is intended to assess muscle strength, reflex actions, and movement control in the upper extremity following a stroke. It has 33 elements and accepts values ranging from 0 to 2. Scores under 31 suggest a weak upper extremity, scores between 32 and 47 show a restricted upper extremity, scores between 48 and 52 indicate a noteworthy upper extremity, and scores between 53 and 66 indicate a full upper extremity.
FMA-UE scale [after treatment (1 month)]
FMA-UE evaluates the hemiparetic arm's mobility, including reflexes, the presence of synergies, and each of the upper limb's independent motions, including grasp. The dysmetria, coordination, and velocity of the patient are also evaluated using items on this scale. It is intended to assess muscle strength, reflex actions, and movement control in the upper extremity following a stroke. It has 33 elements and accepts values ranging from 0 to 2. Scores under 31 suggest a weak upper extremity, scores between 32 and 47 show a restricted upper extremity, scores between 48 and 52 indicate a noteworthy upper extremity, and scores between 53 and 66 indicate a full upper extremity.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Ischemic or hemorhagic hemiplegia
Brunnstrom upper extremity motor stage ≥3
At least 3 months have passed
Modified Ashworth Score ≤2
18-85 year old patients with diagnosis of stroke

Exclusion Criteria:

Aphasia
Cognitive impairment
mini mental test <24
deformity and / or contracture in the upper extremity
Patients diagnosed with KBAS

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Canan Avcı, Specialist of physical medicine and rehabilitation, Istanbul Physical Medicine Rehabilitation Training and Research Hospital

ClinicalTrials.gov Identifier:

NCT05815823

Other Study ID Numbers:

2015/14/01

First Posted:

Apr 18, 2023

Last Update Posted:

Apr 18, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Canan Avcı, Specialist of physical medicine and rehabilitation, Istanbul Physical Medicine Rehabilitation Training and Research Hospital

stroke

upper extremity

robot-assisted therapy

armeo

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Apr 18, 2023