Tele-Rehabilitation Pilot Evaluation Study

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Pneumonia; Fractures, Bone; Fall; Lower Limb Amputation; Deconditioning; Lower Limb Joint Replacement (Hip or Knee); Musculoskeletal Conditions (e.g., Tendinitis, Capsulitis)
• Intervention / Treatment: Behavioral: Tele-rehabilitation; Behavioral: Usual care

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 117549
    • Miho Asano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
EQ-5D	Perceived Health Status and Quality of Life	12-weeks
CESD	The Center for Epidemiological Studies Depression Scale	12-weeks
IADL	The Lawton Instrumental Activities of Daily Living (IADL) Scale	12-weeks
Barthel Index	Barthel Index of Activities of Daily Living	12-weeks
Health Service Utilization	Use of Health Services over the past three months	12-weeks

Collaborators and Investigators

• Sponsor: National University of Singapore
• Investigators: Principal Investigator: Miho Asano, PhD, National University of Singapore

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2018
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: January 11, 2018
• First Submitted That Met QC Criteria: January 23, 2018
• First Posted (Actual): January 24, 2018

Study Record Updates

• Last Update Posted (Actual): August 19, 2019
• Last Update Submitted That Met QC Criteria: August 15, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Fractures, Bone; Bursitis
• Other Study ID Numbers: MHHISDRFP16217

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No