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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04259294
Other study ID # HongKongPOLYU
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2018
Est. completion date May 31, 2019

Study information

Verified date February 2020
Source The Hong Kong Polytechnic University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date May 31, 2019
Est. primary completion date May 31, 2019
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Hong Kong The Hong Kong Polytechnic University Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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)
Primary 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)
Primary 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 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) Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)
Secondary 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) Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)
Secondary 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) Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)
Secondary 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) Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)
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