Tele-Rehabilitation Pilot Evaluation Study

Stroke Clinical Trial

Official title:

Tele-Rehabilitation Pilot Evaluation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03409354
• Other study ID #: MHHISDRFP16217
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

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

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