NCT04308772

Brief Summary

Web-based physiotherapy might improve care following knee arthroscopy. For this study half of the participants will receive usual care (printed leaflet) and half will receive 6 weeks of web-based physiotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

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 25, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 16, 2020

Completed
Last Updated

March 16, 2020

Status Verified

March 1, 2020

Enrollment Period

4 months

First QC Date

March 10, 2020

Last Update Submit

March 12, 2020

Conditions

Keywords

kneearthroscopyphysiotherapyweb-based

Outcome Measures

Primary Outcomes (1)

  • Change in Knee Injury and Osteoarthritis Outcome Score (KOOS).

    The KOOS is a patient reported outcome measure, developed to assess the patients' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury. It consists of 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL).The KOOS is self-administered and takes approximately 10 minutes to complete. The KOOS is reliable, responsive to surgery and physical therapy and can be used to evaluate the course of knee injury and treatment outcomes (Roos et al.,1998).

    Baseline to 6 weeks.

Secondary Outcomes (3)

  • Change in Cincinnati Sports Activity Scale (CSAS)

    Baseline to 6 weeks.

  • Adherence to exercise programme

    Weekly for 6 weeks

  • Health Resource Form

    Week 6

Study Arms (2)

Usual Care

NO INTERVENTION

Those randomised to the usual care arm will receive a leaflet which contains a standard programme of exercises Participants will be asked to complete their exercise programme as prescribed (at least once per day).

Web-based physiotherapy

EXPERIMENTAL

Participants will receive a six week exercise programme, based on those in the usual care exercise sheet delivered via the web-based physio website (www.giraffehealth.com).

Behavioral: Web-based Physiotherapy

Interventions

Participants will receive an exercise programme, based on those patients usually get in the form of an exercise leaflet, delivered via a web-based physio website (www.giraffehealth.com). Participants will be asked to complete their exercise programme as prescribed (at least once each day) and to fill out an online exercise diary which the physiotherapist can see remotely from the clinical site.

Web-based physiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have undergone Knee Arthroscopy surgery.
  • Access to a personal computer/tablet or smart phone with an email address and internet connection
  • Be able to understand English.

You may not qualify if:

  • Infection or other post-operative complications
  • Other significant co-morbidities for which exercise is contra-indicated
  • Unwilling to be randomised to intervention/control group
  • Taking part in another research project

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Elizabeth University Hospital

Glasgow, G51 4TF, United Kingdom

Location

Study Officials

  • Spiros Nikologiannis

    Glasgow Caledonian University

    PRINCIPAL INVESTIGATOR

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
SPONSOR

Study Record Dates

First Submitted

March 10, 2020

First Posted

March 16, 2020

Study Start

June 25, 2018

Primary Completion

October 29, 2018

Study Completion

December 31, 2018

Last Updated

March 16, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations