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

NCT04436770 | Suspended

• 1 other identifier: 13/8.02.2018
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke Sequelae

Keywords

Virtual Reality; Physiotherapy; Recovery

Outcome Measures

Primary Outcomes (1)

• 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.

  One year since the beginning of the research

Secondary Outcomes (1)

• 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.

  One year since the beginning of the research

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Standard physiotherapy and OT

Other: Standard Physiotherapy

Experimental

EXPERIMENTAL

Virtual Reality Therapy and OT

Other: Non-immersive virtual reality therapy

Interventions

Non-immersive virtual reality therapy OTHER

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.

Also known as: Occupational therapy exercises

Experimental

Standard Physiotherapy OTHER

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.

Also known as: Occupational therapy exercises

Control Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Transilvania University of Brasov: lead
• Spitalul Clinic de Psihiatrie si Neurologie Brasov: collaborator

Study Sites (1)

Clinical Hospital of Psychiatry and Neurology

Brasov, Brașov County, 500123, Romania

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 18, 2020
• Study Start: July 18, 2019
• Primary Completion: February 28, 2020
• Study Completion: December 31, 2020
• Last Updated: June 18, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)