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Medical Recovery and Social Reintegration for Post-stroke Patients Using Virtual Reality

Primary Purpose

Stroke Sequelae

Status
Suspended
Phase
Not Applicable
Locations
Romania
Study Type
Interventional
Intervention
Non-immersive virtual reality therapy
Standard Physiotherapy
Sponsored by
Transilvania University of Brasov
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke Sequelae focused on measuring Virtual Reality, Physiotherapy, Recovery

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. stroke survivors after the acute phase, at least 6 weeks post-stroke;
  2. stroke survivors within no more than 4 years after stroke,
  3. at least 30-degree flexion and scapulohumeral abduction against gravity.
  4. elbow flexion of at least 30 degrees
  5. hip flexion of at least 30 degrees
  6. knee flexion of at least 30 degrees

Exclusion Criteria:

  1. no severe cognitive impairments,
  2. no global or transcortical sensory aphasia,
  3. no other dysfunctions in the upper extremity such as surgery, fractures, shoulder arthritis or severe pain,
  4. no other dysfunctions in the lower extremity such as surgery, fractures, arthritis or severe pain,
  5. without anaemia
  6. without atrial fibrillation
  7. without NYHA class IV heart failure

Sites / Locations

  • Clinical Hospital of Psychiatry and Neurology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Experimental

Arm Description

Standard physiotherapy and OT

Virtual Reality Therapy and OT

Outcomes

Primary Outcome Measures

The number of patients for whom tailored Virtual Reality therapy is more efficient than standard tailored physiotherapy in the recovery of post-stroke sequelae.
Determining the factors and parameters that influence or enhance post-stroke recovery capacity using new recovery methods, such as non-immersive virtual reality. The assessment tools are: the Fugl-Meyer assessment for the upper extremity (FMUE), Fugl-Meyer assessment for the lower extremity (FMLE), the Modified Rankin Scale (MRS), the Functional Independence Measure (FIM), the Active Range of Motion (AROM), the Manual Muscle Testing (MMT), the Modified Ashworth Scale (MAS), the Functional Reach Test (FRT), and Timed Up and Go Test (TUG). The patients are assessed by recovery medical doctors (physiatrists) regarding FIM, MAS and MRS. While FMUE, FMLE, AROM, MMT, FRT, TUG are assessed by trained physiotherapists, with at least 5 years of experience in stroke sequelae physiotherapy and evaluation.

Secondary Outcome Measures

The number of patients for whom heart disease and other elderly condition, age or gender are influencing the capacity to the recovery of post-stroke patients.
Collecting data related to age, gender, time after stroke, other conditions present (such as hypertension, dyslipidemia, diabetes, ischemic coronary disease, etc.) and determining the links between post-stroke recovery capacity and these factors using statistical software programs and analysis.

Full Information

First Posted
June 11, 2020
Last Updated
June 15, 2020
Sponsor
Transilvania University of Brasov
Collaborators
Spitalul Clinic de Psihiatrie si Neurologie Brasov
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1. Study Identification

Unique Protocol Identification Number
NCT04436770
Brief Title
Medical Recovery and Social Reintegration for Post-stroke Patients Using Virtual Reality
Official Title
Medical Recovery and Social Reintegration for Post-stroke Patients With Sequelae Using Virtual Reality
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Suspended
Why Stopped
Due to the COVID-19 pandemic
Study Start Date
July 18, 2019 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Transilvania University of Brasov
Collaborators
Spitalul Clinic de Psihiatrie si Neurologie Brasov

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Application of Virtual Reality therapy and occupational therapy versus and standard physiotherapy and occupational therapy to patients with post-stroke sequelae, using specifical assessment tools, standard physiotherapy and occupational therapy programs.
Detailed Description
Initial and final clinical and functional evaluation of patients with post-stroke sequelae, storage and use of data obtained. Collection and access of demographic and clinical data of patients included in the study (respecting the principle of confidentiality and non-publication of personal data) only by staff involved in the research project and working in the Clinical Hospital of Psychiatry and Neurology in Brasov. Application of Virtual Reality therapy and occupational therapy versus and standard physiotherapy and occupational therapy to patients who meet the criteria for inclusion in the study (scapulohumeral flexion and abduction of at least 20 degrees, elbow flexion of at least 20 degrees, hip and knee flexion of at least 20 degrees, without severe aphasia or severe behavioural/cognitive disorders). Use of data obtained from the application of Virtual Reality therapy at home, through Telerehabilitation, if patients procure alone or through sponsorship/donation the equipment necessary to continue the Virtual Reality therapy program at home, taking into account that the technology purchased through the project allows this.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Sequelae
Keywords
Virtual Reality, Physiotherapy, Recovery

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Standard physiotherapy and OT
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Virtual Reality Therapy and OT
Intervention Type
Other
Intervention Name(s)
Non-immersive virtual reality therapy
Other Intervention Name(s)
Occupational therapy exercises
Intervention Description
Non-immersive Virtual Reality (VR) therapy exercises, based on assessment, and occupational therapy exercises, for upper extremity or lower extremity. For the upper extremity, daily, from 20-40 to minutes of VR therapy plus 20-40 minutes of occupational therapy exercises, according to the patient's capacity of VR training, as entire therapy for upper extremity don't exceed 60 minutes. For the lower extremity, from 20-40 to minutes of VR therapy plus 20-40 minutes of occupational therapy exercises, according to the patient's capacity of VR training, as entire therapy for the lower extremity don't exceed 60 minutes. The protocol for occupational therapy exercises for the hand included the use of the Canadian plate, thick and thin grip training, lateral and palmar pinch as well as wrist extensor strengthening tasks. For the ankle and foot, analytical and dexterity exercises using Mirror therapy and alone were used.
Intervention Type
Other
Intervention Name(s)
Standard Physiotherapy
Other Intervention Name(s)
Occupational therapy exercises
Intervention Description
Standard physiotherapy program, based on assessment, plus occupational therapy exercises, for upper extremity or lower extremity. For the upper extremity, daily, 30 minutes of standard physiotherapy plus 30 minutes of occupational therapy exercises. For the lower extremity, daily, 30 minutes of standard physiotherapy plus 30 minutes of occupational therapy exercises. The protocol for occupational therapy exercises for the hand included the use of the Canadian plate, thick and thin grip training, lateral and palmar pinch as well as wrist extensor strengthening tasks. For the ankle and foot, analytical and dexterity exercises were used.
Primary Outcome Measure Information:
Title
The number of patients for whom tailored Virtual Reality therapy is more efficient than standard tailored physiotherapy in the recovery of post-stroke sequelae.
Description
Determining the factors and parameters that influence or enhance post-stroke recovery capacity using new recovery methods, such as non-immersive virtual reality. The assessment tools are: the Fugl-Meyer assessment for the upper extremity (FMUE), Fugl-Meyer assessment for the lower extremity (FMLE), the Modified Rankin Scale (MRS), the Functional Independence Measure (FIM), the Active Range of Motion (AROM), the Manual Muscle Testing (MMT), the Modified Ashworth Scale (MAS), the Functional Reach Test (FRT), and Timed Up and Go Test (TUG). The patients are assessed by recovery medical doctors (physiatrists) regarding FIM, MAS and MRS. While FMUE, FMLE, AROM, MMT, FRT, TUG are assessed by trained physiotherapists, with at least 5 years of experience in stroke sequelae physiotherapy and evaluation.
Time Frame
One year since the beginning of the research
Secondary Outcome Measure Information:
Title
The number of patients for whom heart disease and other elderly condition, age or gender are influencing the capacity to the recovery of post-stroke patients.
Description
Collecting data related to age, gender, time after stroke, other conditions present (such as hypertension, dyslipidemia, diabetes, ischemic coronary disease, etc.) and determining the links between post-stroke recovery capacity and these factors using statistical software programs and analysis.
Time Frame
One year since the beginning of the research

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: stroke survivors after the acute phase, at least 6 weeks post-stroke; stroke survivors within no more than 4 years after stroke, at least 30-degree flexion and scapulohumeral abduction against gravity. elbow flexion of at least 30 degrees hip flexion of at least 30 degrees knee flexion of at least 30 degrees Exclusion Criteria: no severe cognitive impairments, no global or transcortical sensory aphasia, no other dysfunctions in the upper extremity such as surgery, fractures, shoulder arthritis or severe pain, no other dysfunctions in the lower extremity such as surgery, fractures, arthritis or severe pain, without anaemia without atrial fibrillation without NYHA class IV heart failure
Facility Information:
Facility Name
Clinical Hospital of Psychiatry and Neurology
City
Braşov
State/Province
Brasov
ZIP/Postal Code
500123
Country
Romania

12. IPD Sharing Statement

Plan to Share IPD
No

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Medical Recovery and Social Reintegration for Post-stroke Patients Using Virtual Reality

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