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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03409354
Other study ID # MHHISDRFP16217
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 15, 2018
Est. completion date September 30, 2018

Study information

Verified date August 2019
Source National University, Singapore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

This is a 12-week quasi-experimental trial of a tele-rehabilitation program involving seven sites and up to 600 adults in Singapore.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date September 30, 2018
Est. primary completion date September 30, 2018
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Singapore Miho Asano Singapore

Sponsors (1)

Lead Sponsor Collaborator
National University, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 At 12-weeks post-rehabilitation
Secondary EQ-5D Perceived Health Status and Quality of Life 12-weeks
Secondary CESD The Center for Epidemiological Studies Depression Scale 12-weeks
Secondary IADL The Lawton Instrumental Activities of Daily Living (IADL) Scale 12-weeks
Secondary Barthel Index Barthel Index of Activities of Daily Living 12-weeks
Secondary Health Service Utilization Use of Health Services over the past three months 12-weeks
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