NCT04874181

Brief Summary

Use of SIlverfit 3d to aid in rehab of stroke patients focusing on their shoulder and knee strength

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

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

July 5, 2020

Completed
22 days until next milestone

Study Start

First participant enrolled

July 27, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 5, 2021

Completed
Last Updated

May 5, 2021

Status Verified

July 1, 2020

Enrollment Period

7 months

First QC Date

July 5, 2020

Last Update Submit

May 3, 2021

Conditions

Keywords

virtual realitySilverfit 3Drehabilitation

Outcome Measures

Primary Outcomes (3)

  • To estimate an improvement in muscle strength using the Medical Research Council (MRC) grading following the intervention.

    Use of MRC grade to estimate improvement in muscle strength by a group of trained physiotherapists before, during and after the use of virtual reality equipment.

    3 months

  • estimate how much a patient can do compared to his/her baseline in terms of ability to stand/ambulation/reaching out for objects based on the physiotherapist who first saw the patient.

    Patients will be interviewed on admission by the physiotherapist to find out his/her baseline activities of daily living/strength and limb power. Physiotherapists will assess the patient again on day of discharge to find out how much the patient is able to return to his/her baseline post stroke. This is a descriptive outcome measure as it is only measured by 1 physiotherapist who has seen the patient on admission and then on discharge from hospital.

    3 months

  • increase frequency and intensity of rehab activities in stroke patients

    To increase frequency of rehab activities in patients in terms of percentage of patients who can do, time of each exercise

    6 months

Secondary Outcomes (1)

  • reduce length of stay in ICU

    3 months

Study Arms (1)

Silverfit 3D

EXPERIMENTAL

The subject will use SIlverfit 3D for rehabilitation of his/her shoulder/knee strength post stroke.

Device: Silverfit 3D

Interventions

Virtual reality game used for rehabilitation of stroke patients

Silverfit 3D

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients 21 - 90 years old
  • Diagnosis of stroke of pure motor/sensory type affecting the limbs, all levels of severity and at all stages post stroke, defined by the WHO as "a syndrome of rapidly developing symptoms and signs of focal, and at times global, loss of cerebral function lasting more than 24 hours or leading to death with no apparent cause other than that of vascular origin" (WHO 1989), diagnosed by imaging or neurological examination
  • GCS 14 - 15
  • RASS -1 to +1
  • Blood pressure within 20% of patient's baseline
  • Muscle power at least 2 out of 5 on the affected side, as assessed by the physiotherapist or clinician

You may not qualify if:

  • Age less than 21 or more than 90 years old
  • Neurological instability
  • Poor prognosis/expected withdrawal of treatment/palliative care patient
  • Visual loss/hearing loss
  • Active delirium with inability to cooperate as determined by CAM-ICU positivity
  • Severe cognitive impairment/dementia
  • Haemodynamic instability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tan Tock Seng Hospital

Singapore, 308433, Singapore

Location

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
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Single Arm study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2020

First Posted

May 5, 2021

Study Start

July 27, 2020

Primary Completion

March 2, 2021

Study Completion

April 13, 2021

Last Updated

May 5, 2021

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations