NCT05278403

Brief Summary

Randomized clinical trial based on the application of virtual reality and video games together with physiotherapy treatment in stroke patients, with the main objective of determining their beneficial effects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started May 2022

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

First Submitted

Initial submission to the registry

March 3, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 14, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

May 6, 2022

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2022

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2022

Completed
Last Updated

June 22, 2022

Status Verified

June 1, 2022

Enrollment Period

14 days

First QC Date

March 3, 2022

Last Update Submit

June 21, 2022

Conditions

Outcome Measures

Primary Outcomes (5)

  • Strength

    Strength measurement using the Daniels and Worthingham Scale. Minimum value = 0 , maximum value = 5. Higher scores mean a better outcome.

    One month

  • Spasticity

    Spasticity measurement using the Ashworth modified scale. Minimum value = 0, maximum value = 4. Higher scores mean a worse outcome.

    One month

  • Gait

    Gait measurement using the Tinetti scale. Minimum value = 0, maximum value = 28. Higher scores mean a better outcome.

    One month

  • Balance

    Balance using the Berg Balance Scale. Minimum value = 0, maximum value = 56. Higher scores mean a better outcome.

    One month

  • Joint range

    Joint range measure using goniometer

    One month

Study Arms (2)

Control group

ACTIVE COMPARATOR

Conventional neurological physiotherapy treatment.

Other: Neurological physiotherapy

Experimental group

EXPERIMENTAL

Conventional neurological physiotherapy treatment with the use of virtual reality and video games.

Other: Virtual reality and video gamesOther: Neurological physiotherapy

Interventions

Use of a software in stroke patients' rehabilitation.

Experimental group

Application of conventional physical therapy techniques.

Control groupExperimental group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients receiving neurological physiotherapy treatment.
  • Patients who have suffered a stroke in the last two years.
  • Patients with an age range between 18 and 80 years old.
  • Patients with stroke with the ability to have minimal manual pressure with one limb.

You may not qualify if:

  • Patients with stroke who also have degenerative diseases such as Alzheimer's or Parkinson's.
  • Stroke patients who do not understand the instructions.
  • Patients who have undergone surgery on the evaluated limbs.
  • Patients with scars that limit movement.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Murcia

Murcia, 300100, Spain

Location

MeSH Terms

Conditions

Stroke

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Angel Martínez Carrasco, PhD

    Universidad de Murcia

    STUDY DIRECTOR
  • Francisco Javier Peláez Vélez, Graduated

    Universidad de Murcia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Randomized groups. Participants do not know to which group they are assigned. The other participants are unaware of the purpose of the study.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two randomized groups. A control group and an experimental group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Phd

Study Record Dates

First Submitted

March 3, 2022

First Posted

March 14, 2022

Study Start

May 6, 2022

Primary Completion

May 20, 2022

Study Completion

June 13, 2022

Last Updated

June 22, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations