- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03631524
Using Telerehabilitation Tools to Deliver Quality Therapy to Patients Under Infective Isolation Precautions (IsoRehab2018)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Geoffrey S Samuel, MBBS
- Phone Number: +6597607935
- Email: geoffrey.sithamparapillai.samuel@singhealth.com.sg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 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
|
|
Experimental: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Manual motor power testing
Time Frame: 2 weeks
|
To assess change in the motor function level (as determined by
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Volume of therapy
Time Frame: 2 weeks
|
The number of repetitions of each exercise will be used as corraborative evidence of progress during therapy.
|
2 weeks
|
Functional Independence Measure
Time Frame: 2 weeks
|
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
Time Frame: 2 weeks
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Geoffrey S Samuel, MBBS, Singhealth Pte Ltd
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2017/2994
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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