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CompletedNCT03409354Updated Aug 19, 2019

Tele-Rehabilitation Pilot Evaluation Study

An interventional study of Tele-rehabilitation and Usual care in Fractures, Bone, Stroke and Lower Limb Joint Replacement (Hip or Knee), sponsored by National University of Singapore. Completed at 1 site in Singapore. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2019-08-19.

Sponsored by National University of Singapore · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Non-randomized
Ages
21 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Fractures, Bone
  • Stroke
  • Lower Limb Joint Replacement (Hip or Knee)
  • Lower Limb Amputation
  • Pneumonia
  • Fall
  • Deconditioning
  • Musculoskeletal Conditions (e.g., Tendinitis, Capsulitis)
03

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    Tele-rehabilitation

    Tele-rehabilitation via iPad.

    Behavioral: Tele-rehabilitation

  • Active comparator
    Usual care

    Usual rehabilitation care, prescribed by rehabilitation therapists at participating centers and performed by participants at participating centers.

    Behavioral: Usual care

Interventions

  • BehavioralTele-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.

  • BehavioralUsual care

    Usual rehabilitation care (e.g., PT, OT and ST), prescribed by rehabilitation therapists at participating centers and performed by participants at participating centers.

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: At 12-weeks post-rehabilitation

Secondary outcomes

  1. EQ-5D

    Perceived Health Status and Quality of Life

    Time frame: 12-weeks

  2. CESD

    The Center for Epidemiological Studies Depression Scale

    Time frame: 12-weeks

  3. IADL

    The Lawton Instrumental Activities of Daily Living (IADL) Scale

    Time frame: 12-weeks

  4. Barthel Index

    Barthel Index of Activities of Daily Living

    Time frame: 12-weeks

  5. Health Service Utilization

    Use of Health Services over the past three months

    Time frame: 12-weeks

06

Study locations

1 site
  • Miho Asano
    Singapore, 117549, Singapore
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03409354
Lead sponsor
National University of Singapore
Responsible party
Miho Asano (Assistant Professor, National University of Singapore) — Principal investigator
First posted
Jan 24, 2018
Start date
May 15, 2018
Primary completion
Sep 30, 2018
Completion
Sep 30, 2018
Last update
Aug 19, 2019

Study contacts

Miho Asano, PhD
principal investigator · National University of Singapore

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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