NCT05815823

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

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

January 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

2 years

First QC Date

March 22, 2023

Last Update Submit

April 4, 2023

Conditions

Keywords

strokeupper extremityrobot-assisted therapyarmeo

Outcome Measures

Primary Outcomes (2)

  • FMA-UE scale

    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.

    baseline

  • FMA-UE scale

    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.

    after treatment (1 month)

Study Arms (2)

conventional therapy

EXPERIMENTAL

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

Other: conventional therapy

robot-assisted therapy

EXPERIMENTAL

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

Other: robotic exercise therapyOther: conventional therapy

Interventions

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

Also known as: robotic exercise
robot-assisted therapy

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

conventional therapyrobot-assisted therapy

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist of physical medicine and rehabilitation

Study Record Dates

First Submitted

March 22, 2023

First Posted

April 18, 2023

Study Start

January 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

April 18, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP