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Tele-Rehabilitation Pilot Evaluation Study

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ClinicalTrials.gov Identifier: NCT03409354
Recruitment Status : Completed
First Posted : January 24, 2018
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
Miho Asano, National University, Singapore

Study Description
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Brief Summary:
A proof of concept randomized controlled trial (RCT) only evaluated the National University of Singapore's (NUS) T-Rehab tele-rehabilitation (TR) system at a home setting where rehabilitation was provided on an individual level. The previous RCT was also limited to stroke patients. In addition to stroke, there are many other conditions (such as fractures, lower limb joint replacement, musculoskeletal conditions) require and benefit from rehabilitation. The primary aims of the pilot evaluation study are: (i) To document patient adherence to TR, compared to usual care (ii) To estimate the extent to which TR improves functional status, compared to usual care and (iii) To estimate the cost effectiveness of TR, compared to usual care in eight different health conditions in Singapore.

Condition or disease Intervention/treatment Phase
Fractures, Bone Stroke Lower Limb Joint Replacement (Hip or Knee) Lower Limb Amputation Pneumonia Fall Deconditioning Musculoskeletal Conditions (e.g., Tendinitis, Capsulitis) Behavioral: Tele-rehabilitation Behavioral: Usual care Not Applicable

Detailed Description:
This is a 12-week quasi-experimental trial of a tele-rehabilitation program involving seven sites and up to 600 adults in Singapore.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Tele-Rehabilitation Pilot Evaluation Study
Actual Study Start Date : May 15, 2018
Actual Primary Completion Date : September 30, 2018
Actual Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arms and Interventions
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Arm Intervention/treatment
Experimental: Tele-rehabilitation
Tele-rehabilitation via iPad.
 Behavioral: Tele-rehabilitation
There are five different categories of exercise in the rehabilitation program, which combines both physiotherapy (Category 1 to 4) and occupational therapy components (Category 5). Each tele-therapy session could cover all five categories of exercises. Progression of levels within each exercise within each category should be determined by the tele-therapist and in consultation with the participant.
Active Comparator: Usual care
Usual rehabilitation care, prescribed by rehabilitation therapists at participating centers and performed by participants at participating centers.
 Behavioral: Usual care
Usual rehabilitation care (e.g., PT, OT and ST), prescribed by rehabilitation therapists at participating centers and performed by participants at participating centers.


Outcome Measures
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Primary Outcome Measures :
  1. Adherence to rehabilitation over the course of a 2 week trial period [ Time Frame: At 12-weeks post-rehabilitation ]
    Adherence to the prescribed rehabilitation and exercise therapy will be measured over 12 weeks


Secondary Outcome Measures :
  1. EQ-5D [ Time Frame: 12-weeks ]
    Perceived Health Status and Quality of Life

  2. CESD [ Time Frame: 12-weeks ]
    The Center for Epidemiological Studies Depression Scale

  3. IADL [ Time Frame: 12-weeks ]
    The Lawton Instrumental Activities of Daily Living (IADL) Scale

  4. Barthel Index [ Time Frame: 12-weeks ]
    Barthel Index of Activities of Daily Living

  5. Health Service Utilization [ Time Frame: 12-weeks ]
    Use of Health Services over the past three months


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • at least 21 years of age
  • Admitted into an inpatient or outpatient rehabilitation unit, nursing home or day care centre for an acute or chronic disability
  • Deemed by any members of the multi-disciplinary rehabilitation team to potentially able to safely receive and benefit from rehabilitation post-discharge
  • Cognitively able to understand and follow instructions (the Abbreviated Mental Test's score of 6 or above (out of 10).

Exclusion Criteria:

  • Patients with previous seizure episodes
  • Patients with limb musculoskeletal pain of at least moderate intensity (visual analogue Scale > 6 out of 10)
  • Patients with pacemakers.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03409354


Locations
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Singapore
Miho Asano
Singapore, Singapore, 117549
Sponsors and Collaborators
National University, Singapore
Investigators
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Principal Investigator: Miho Asano, PhD National University, Singapore
More Information
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Responsible Party: Miho Asano, Assistant Professor, National University, Singapore
ClinicalTrials.gov Identifier: NCT03409354    
Other Study ID Numbers: MHHISDRFP16217
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bursitis
Tendinopathy
Fractures, Bone
Joint Diseases
 Musculoskeletal Diseases
Muscular Diseases
Tendon Injuries
Wounds and Injuries