NCT04259294

Brief Summary

The investigators will investigate the effects of a home-based occupational therapy telerehabilitation (TR) via smartphones in enhancing functional and motor performances, and fall efficacy, for outpatients receiving day hospital rehabilitation after hip fracture surgery. This is a feasibility randomized controlled trial with two groups - experimental and comparison groups, involving older adults after hip fracture surgery within 12 weeks attending the Geriatric Day Hospital. Patients will be assessed at baseline, immediately post 3-weeks intervention, and follow-up after 3-weeks for motor performances, daily activities functioning and fall efficacy. The experimental group will receive home program using the use of Caspar Health e-system and a mobile app in smartphones, while the comparison group will receive paper-and-pencil instructions for the home program on weekly basis, for 3 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

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

Study Start

First participant enrolled

June 1, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2020

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
Last Updated

February 6, 2020

Status Verified

February 1, 2020

Enrollment Period

12 months

First QC Date

January 9, 2020

Last Update Submit

February 4, 2020

Conditions

Outcome Measures

Primary Outcomes (4)

  • Timed up and go test (TUG)

    It measures fall risk and progress in walking speed (Change from baseline at post 3-week intervention and follow-up after 3 weeks)

    Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)

  • The Functional Reach Test (FR)

    It measures balance (Change from baseline at post 3-week intervention and follow-up after 3 weeks)

    Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)

  • Muscle strength (MS)

    It will be measured using a force gauge on the strength of Quadriceps of both the affected and the non-affected legs (Change from baseline at post 3-week intervention and follow-up after 3 weeks)

    Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)

  • The Pain Visual Analogue Scale (VAS)

    It measures pain intensity. It consists of a 100mm horizontal line anchored with two opposite labels, i.e. labelled at the left end as 'no pain' (0mm) and at the right end as 'very severe pain' (100mm). (Change from baseline at post 3-week intervention and follow-up after 3 weeks)

    Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)

Secondary Outcomes (4)

  • The Hong Kong Chinese version of the Modified Barthel index (MBI)

    Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)

  • The Hong Kong Chinese version of the Lawton Instrumental Activities of Daily Living (IADL)

    Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)

  • The Fall Efficacy Scale (FES)

    Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)

  • The Morse Fall Scale (MFS)

    Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)

Study Arms (2)

Telerehabilitation group via mobile apps

EXPERIMENTAL

The experimental group will receive home-based treatment program through mobile apps

Behavioral: Caspar Telerehabilitation

Control group via paper and pencil instructions

ACTIVE COMPARATOR

The control group will receive treatment via written home program sheets

Behavioral: Caspar Telerehabilitation

Interventions

The experimental group will receive home-based treatment program through mobile apps while control group will receive through a written home program sheets. The training contents will be equivalent, including trunk and lower limb strengthening and stretching, coordination, balance, and functional exercises that will be related to patients' daily living activities in their home. The frequency and duration of the home program will be compromised by both the therapist and the patient. The videos of the home program will be sent to patients' app in smartphone by the therapist in the experimental group. Patients will perform the exercises while watching the videos in the app. After each exercise will be done, patient's performance feedback will be captured by the smartphone and will be sent back to the case therapist each time through the app while those in the control group will record their performance in a log sheet given by the therapists.

Control group via paper and pencil instructionsTelerehabilitation group via mobile apps

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary diagnosis of hip fracture
  • Post-hip surgery within 12 weeks
  • Aged 60 years old or above
  • Medically stable
  • With Abbreviated Mental Test scored 6 or above
  • Having at least one functional limitation in the basic activities of daily living assessments

You may not qualify if:

  • The hip fracture is the result of malignancy
  • There is risk of falls due to postural hypotension
  • Either patients or caregiver do not understand Cantonese, English or Mandarin instructions
  • They do not use a smartphone
  • They are unable to read the instructions on the screen of the smartphone because of visual difficulty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hung Hom, Hong Kong

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 9, 2020

First Posted

February 6, 2020

Study Start

June 1, 2018

Primary Completion

May 31, 2019

Study Completion

May 31, 2019

Last Updated

February 6, 2020

Record last verified: 2020-02

Locations