Tele-Rehabilitation Pilot Evaluation Study
Primary Purpose
Fractures, Bone, Stroke, Lower Limb Joint Replacement (Hip or Knee)
Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Tele-rehabilitation
Usual care
Sponsored by
About this trial
This is an interventional health services research trial for Fractures, Bone
Eligibility 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.
Sites / Locations
- Miho Asano
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tele-rehabilitation
Usual care
Arm Description
Tele-rehabilitation via iPad.
Usual rehabilitation care, prescribed by rehabilitation therapists at participating centers and performed by participants at participating centers.
Outcomes
Primary Outcome Measures
Adherence to rehabilitation over the course of a 2 week trial period
Adherence to the prescribed rehabilitation and exercise therapy will be measured over 12 weeks
Secondary Outcome Measures
EQ-5D
Perceived Health Status and Quality of Life
CESD
The Center for Epidemiological Studies Depression Scale
IADL
The Lawton Instrumental Activities of Daily Living (IADL) Scale
Barthel Index
Barthel Index of Activities of Daily Living
Health Service Utilization
Use of Health Services over the past three months
Full Information
NCT ID
NCT03409354
First Posted
January 11, 2018
Last Updated
August 15, 2019
Sponsor
National University of Singapore
1. Study Identification
Unique Protocol Identification Number
NCT03409354
Brief Title
Tele-Rehabilitation Pilot Evaluation Study
Official Title
Tele-Rehabilitation Pilot Evaluation Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
May 15, 2018 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Singapore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fractures, Bone, Stroke, Lower Limb Joint Replacement (Hip or Knee), Lower Limb Amputation, Pneumonia, Fall, Deconditioning, Musculoskeletal Conditions (e.g., Tendinitis, Capsulitis)
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tele-rehabilitation
Arm Type
Experimental
Arm Description
Tele-rehabilitation via iPad.
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Usual rehabilitation care, prescribed by rehabilitation therapists at participating centers and performed by participants at participating centers.
Intervention Type
Behavioral
Intervention Name(s)
Tele-rehabilitation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
Usual rehabilitation care (e.g., PT, OT and ST), prescribed by rehabilitation therapists at participating centers and performed by participants at participating centers.
Primary Outcome Measure Information:
Title
Adherence to rehabilitation over the course of a 2 week trial period
Description
Adherence to the prescribed rehabilitation and exercise therapy will be measured over 12 weeks
Time Frame
At 12-weeks post-rehabilitation
Secondary Outcome Measure Information:
Title
EQ-5D
Description
Perceived Health Status and Quality of Life
Time Frame
12-weeks
Title
CESD
Description
The Center for Epidemiological Studies Depression Scale
Time Frame
12-weeks
Title
IADL
Description
The Lawton Instrumental Activities of Daily Living (IADL) Scale
Time Frame
12-weeks
Title
Barthel Index
Description
Barthel Index of Activities of Daily Living
Time Frame
12-weeks
Title
Health Service Utilization
Description
Use of Health Services over the past three months
Time Frame
12-weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miho Asano, PhD
Organizational Affiliation
National University of Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Miho Asano
City
Singapore
ZIP/Postal Code
117549
Country
Singapore
12. IPD Sharing Statement
Plan to Share IPD
No
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Tele-Rehabilitation Pilot Evaluation Study
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