NCT03409354

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 24, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

May 15, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

August 19, 2019

Status Verified

August 1, 2019

Enrollment Period

5 months

First QC Date

January 11, 2018

Last Update Submit

August 15, 2019

Conditions

Fractures, BoneStrokeLower Limb Joint Replacement (Hip or Knee)Lower Limb AmputationPneumoniaFallDeconditioningMusculoskeletal Conditions (e.g., Tendinitis, Capsulitis)

Outcome Measures

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

    At 12-weeks post-rehabilitation

Secondary Outcomes (5)

  • EQ-5D

    12-weeks

  • CESD

    12-weeks

  • IADL

    12-weeks

  • Barthel Index

    12-weeks

  • Health Service Utilization

    12-weeks

Study Arms (2)

Tele-rehabilitation

EXPERIMENTAL

Tele-rehabilitation via iPad.

Behavioral: Tele-rehabilitation

Usual care

ACTIVE COMPARATOR

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

Behavioral: Usual care

Interventions

Tele-rehabilitationBEHAVIORAL

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.

Tele-rehabilitation
Usual careBEHAVIORAL

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

Usual care

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Miho Asano

Singapore, 117549, Singapore

Location

MeSH Terms

Conditions

Fractures, BoneStrokePneumoniaTendinopathyBursitis

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Wounds and InjuriesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesRespiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesMuscular DiseasesMusculoskeletal DiseasesTendon InjuriesJoint Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Miho Asano, PhD

    National University of Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 11, 2018

First Posted

January 24, 2018

Study Start

May 15, 2018

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

August 19, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)