The Effects of a Home-based Occupational Therapy Tele-rehabilitation for Outpatients After Hip Fracture Surgery
Primary Purpose
Telerehabilitation
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Caspar Telerehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Telerehabilitation
Eligibility Criteria
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
Sites / Locations
- The Hong Kong Polytechnic University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Telerehabilitation group via mobile apps
Control group via paper and pencil instructions
Arm Description
The experimental group will receive home-based treatment program through mobile apps
The control group will receive treatment via written home program sheets
Outcomes
Primary Outcome Measures
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)
The Functional Reach Test (FR)
It measures balance (Change from baseline at 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)
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)
Secondary Outcome Measures
The Hong Kong Chinese version of the Modified Barthel index (MBI)
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)
The Hong Kong Chinese version of the Lawton Instrumental Activities of Daily Living (IADL)
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)
The Fall Efficacy Scale (FES)
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)
The Morse Fall Scale (MFS)
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)
Full Information
NCT ID
NCT04259294
First Posted
January 9, 2020
Last Updated
February 4, 2020
Sponsor
The Hong Kong Polytechnic University
1. Study Identification
Unique Protocol Identification Number
NCT04259294
Brief Title
The Effects of a Home-based Occupational Therapy Tele-rehabilitation for Outpatients After Hip Fracture Surgery
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
May 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Telerehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telerehabilitation group via mobile apps
Arm Type
Experimental
Arm Description
The experimental group will receive home-based treatment program through mobile apps
Arm Title
Control group via paper and pencil instructions
Arm Type
Active Comparator
Arm Description
The control group will receive treatment via written home program sheets
Intervention Type
Behavioral
Intervention Name(s)
Caspar Telerehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Timed up and go test (TUG)
Description
It measures fall risk and progress in walking speed (Change from baseline at post 3-week intervention and follow-up after 3 weeks)
Time Frame
Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)
Title
The Functional Reach Test (FR)
Description
It measures balance (Change from baseline at post 3-week intervention and follow-up after 3 weeks)
Time Frame
Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)
Title
Muscle strength (MS)
Description
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)
Time Frame
Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)
Title
The Pain Visual Analogue Scale (VAS)
Description
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)
Time Frame
Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)
Secondary Outcome Measure Information:
Title
The Hong Kong Chinese version of the Modified Barthel index (MBI)
Description
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)
Time Frame
Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)
Title
The Hong Kong Chinese version of the Lawton Instrumental Activities of Daily Living (IADL)
Description
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)
Time Frame
Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)
Title
The Fall Efficacy Scale (FES)
Description
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)
Time Frame
Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)
Title
The Morse Fall Scale (MFS)
Description
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)
Time Frame
Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hong Kong
ZIP/Postal Code
Hung Hom
Country
Hong Kong
12. IPD Sharing Statement
Learn more about this trial
The Effects of a Home-based Occupational Therapy Tele-rehabilitation for Outpatients After Hip Fracture Surgery
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