The Effects of a Home-based Occupational Therapy Tele-rehabilitation for Outpatients After Hip Fracture Surgery

February 4, 2020 updated by: Kenneth N. K. Fong, The Hong Kong Polytechnic University

The Effects of a Home-based Occupational Therapy Tele-rehabilitation Via Smartphones for Outpatients After Hip Fracture Surgery in Hong Kong: A Feasibility Randomized Controlled Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong, Hung Hom
        • The Hong Kong Polytechnic University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

56 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Telerehabilitation group via mobile apps
The experimental group will receive home-based treatment program through mobile apps
Behavioral: Caspar Telerehabilitation

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.
Active Comparator: Control group via paper and pencil instructions
The control group will receive treatment via written home program sheets
Behavioral: Caspar Telerehabilitation

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Timed up and go test (TUG)
Time Frame: Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)
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)
Time Frame: Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)
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)
Time Frame: Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)
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)
Time Frame: Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Hong Kong Chinese version of the Modified Barthel index (MBI)
Time Frame: Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)
It measures performance in basic activities of daily living. The item scores range from '0', which indicates an inability to perform, to a maximum of '5, 10 or 15', which represents total independence. The total items score of 100 indicates complete independence in self-care performance. (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 Hong Kong Chinese version of the Lawton Instrumental Activities of Daily Living (IADL)
Time Frame: Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)
It assesses nine domains of function skills (ability to use telephone, shopping, meal preparation, laundry, housekeeping, handyman work, and transportation, medication and money management) The item scores range from '0' which indicates an inability to perform, to a maximum of '2,3 or 4' which represents total independence (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 Fall Efficacy Scale (FES)
Time Frame: Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)
FES is a questionnaire to assess the level of confidence when patient perform activities of daily living without fear of fall. FES is a ten-item test rated on a 10-point scale from not confident at all to completely confident (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 Morse Fall Scale (MFS)
Time Frame: Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)
MFS predict the likelihood of falls. It consists of 6 variables: history of fall, the presence of a secondary diagnosis, the use of ambulatory aids, the administration of intravenous therapy, types of gait and mental status. MFS is rated as follows, 0: No risk for falls; <25: Low risk; 25-45: Moderate risk ; >45: High risk (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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hong Kong Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 6, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HongKongPOLYU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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