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Clinical Trials/NCT03631524
NCT03631524
Unknown
N/A

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

Singapore General Hospital0 sites60 target enrollmentNovember 15, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Deconditioning, Isolation Precautions
Sponsor
Singapore General Hospital
Enrollment
60
Primary Endpoint
Manual motor power testing
Last Updated
7 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
November 15, 2018
End Date
December 20, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Geoffrey Sithamparapillai Samuel

Consultant, Department of Rehabilitation Medicine

Singapore General Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Manual motor power testing

Time Frame: 2 weeks

To assess change in the motor function level (as determined by 1. Medical Research Council (MRC) Manual Muscle Testing (MMT)) at the end of 2 weeks of assessment. 2. To assess change of quadriceps strength using a handheld dynamometer at the end of 2 weeks of assessment

Secondary Outcomes

  • Volume of therapy(2 weeks)
  • Functional Independence Measure(2 weeks)
  • Level of anxiety/ depression(2 weeks)

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