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

Study Overview
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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.

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

Conditions
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Deconditioning, Isolation Precautions

Intervention / Treatment
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* Device: Telerehabilitation


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two arm single blinded RCT
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conventional therapy<br>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 | |
| Experimental: Intervention arm<br>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. | Device: Telerehabilitation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Manual motor power testing | To assess change in the motor function level (as determined by Medical Research Council (MRC) Manual Muscle Testing (MMT)) at the end of 2 weeks of assessment. To assess change of quadriceps strength using a handheld dynamometer at the end of 2 weeks of assessment | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of therapy | The number of repetitions of each exercise will be used as corraborative evidence of progress during therapy. | 2 weeks | 
| Functional Independence Measure | The FIM Provides a uniform system of measurement for disability based on the International Classification of Impairment, Disabilities and Handicaps; measures the level of a patient's disability and indicates how much assistance is required for the individual to carry out activities of daily living based on their score in 18 categories (13 motor and 5 cognitive function items). Each category or item is rated on a 7-point scale (1 = total assistance required, 7 = fully independent). Coster, W. J., Haley, S. M., et al. (2006). Measuring patient-reported outcomes after discharge from inpatient rehabilitation settings. J Rehabil Med 38(4): 237-242. | 2 weeks | 
| Level of anxiety/ depression | Hospital Anxiety and Depression Score. The HADS is a fourteen item clinical assessment scale to assess levels of anxiety and depression. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The HADS uses an ordinal scale. A number of researchers have explored HADS data to establish the cut-off points for diagnosis of anxiety or depression. A systematic review of a large number of studies identified a cut-off point of 8/21 for anxiety or depression. For anxiety (HADS-A) this gave a specificity of 0.78 and a sensitivity of 0.9. For depression (HADS-D) this gave a specificity of 0.79 and a sensitivity of 0.83. | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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deconditioning, isolation precautions, telerehabilitation