Using Telerehabilitation Tools to Deliver Quality Therapy to Patients Under Infective Isolation Precautions

NCT ID: NCT03631524

Last Updated: 2018-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-15

Study Completion Date

2019-12-20

Brief Summary

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Single blinded Randomised Controlled trial comparing standard therapy to the intervention of up to 1 hour of physiotherapist-prescribed resistive training exercises administered via a telerehabilitation device per day in addition to standard therapy for a total of 10 sessions over a 2 week period. Total recruitment: 60 patients.

Detailed Description

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This is a single blinded randomised control trial. From August 2018 to March 2019, a total of 60 subjects, who match the inclusion exclusion criteria, will be recruited from patients transferred to the SGH Isolation wards.

They will be randomly assigned to control or treatment arm based on a block randomisation strategy predetermined and held by an independent party.

The treatment arm will be given up to 1 hour of physiotherapist-prescribed resistive training exercises administered via a telerehabilitation device per day in addition to standard therapy for a total of 10 sessions over a 2 week period. They will be evaluated for motor strength, activity of daily living performance, mood and perceived level of health.

The control arm will be subject to the same assessments as the treatment arm at the start and end of the two week period. They will receive standard care in the ward including physiotherapy as prescribed by the managing team.

The assessors will be blinded to the arm of the study the subjects will be assigned to and will be independent of the terating physiotherapist.

1.1. Hypothesis We propose that for patients with deconditioning after a prolonged period of hospitalization and needing inpatient isolation precautions, that a 2-week course of daily, up to 1-hour long, physiotherapist-developed resistive training exercises will result in a 20% improvement in the motor power and a corresponding improvement in motor functioning and the perceived quality of life compared to a control group receiving standard therapy.

Conditions

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Deconditioning, Isolation Precautions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two arm single blinded RCT
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Block Randomisation, Initial and final outcome assessors blinded to treatment arm

Study Groups

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Conventional therapy

The control arm will be subject to the same assessments as the treatment arm at the start and end of the two week period. They will receive standard care in the ward including physiotherapy as prescribed by the managing team

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention arm

The treatment arm will be given up to 1 hour of physiotherapist-prescribed resistive training exercises administered via a telerehabilitation device per day in addition to standard therapy for a total of 10 sessions over a 2 week period. They will be evaluated for motor strength, activity of daily living performance, mood and perceived level of health.

Group Type EXPERIMENTAL

Telerehabilitation

Intervention Type DEVICE

The treatment arm will be given up to 1 hour of physiotherapist-prescribed resistive training exercises administered via a telerehabilitation device per day in addition to standard therapy for a total of 10 sessions over a 2 week period.

Interventions

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Telerehabilitation

The treatment arm will be given up to 1 hour of physiotherapist-prescribed resistive training exercises administered via a telerehabilitation device per day in addition to standard therapy for a total of 10 sessions over a 2 week period.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* • Able to give consent

* Admitted to hospital for at least 5 days
* MMT power grading 2-4/5
* Isolated for prevention of transmission of MDROs

Exclusion Criteria

* • Unable or unwilling to consent for the trial

* Assessed by managing team to be fit for discharge within the next 2 weeks
* Pregnant women
* Underlying medical disorders that result in pre-existing lower limb weakness
Minimum Eligible Age

21 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Medical Research Council (NMRC), Singapore

OTHER_GOV

Sponsor Role collaborator

Singapore General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Geoffrey Sithamparapillai Samuel

Consultant, Department of Rehabilitation Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Geoffrey S Samuel, MBBS

Role: PRINCIPAL_INVESTIGATOR

Singhealth Pte Ltd

Central Contacts

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Geoffrey S Samuel, MBBS

Role: CONTACT

+6597607935

References

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Morgan DJ, Diekema DJ, Sepkowitz K, Perencevich EN. Adverse outcomes associated with Contact Precautions: a review of the literature. Am J Infect Control. 2009 Mar;37(2):85-93. doi: 10.1016/j.ajic.2008.04.257.

Reference Type BACKGROUND
PMID: 19249637 (View on PubMed)

Ploutz-Snyder LL, Downs M, Ryder J, Hackney K, Scott J, Buxton R, Goetchius E, Crowell B. Integrated resistance and aerobic exercise protects fitness during bed rest. Med Sci Sports Exerc. 2014 Feb;46(2):358-68. doi: 10.1249/MSS.0b013e3182a62f85.

Reference Type BACKGROUND
PMID: 24441215 (View on PubMed)

Other Identifiers

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2017/2994

Identifier Type: -

Identifier Source: org_study_id

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