Web-Based Physiotherapy Following Knee Arthroscopy

March 12, 2020 updated by: Glasgow Caledonian University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Despite its minimally invasive nature, studies have shown that patients undergoing arthroscopic meniscectomy have pain, effusion, loss of range of motion, functional, neuromuscular and biomechanical changes, loss of quadriceps muscle strength, and a reduced quality of life (Durand et al.,1993;Goodwin and Morrissey,2003; Glatthorn et al.,2010). With changes in service delivery patients following arthroscopy only receive a printed leaflet. Web-based physiotherapy may offer offer cost effective support to patients. Therefore, the aim of this study is to undertake a single blind, randomised controlled pilot study examining the effectiveness of a six week web-based physiotherapy programme compared to usual care alone, for people following knee arthroscopy and to gather essential information for the planning of a definitive trial.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • 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

  • United Kingdom
      • Glasgow, United Kingdom, G51 4TF
        • Queen Elizabeth University Hospital

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

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
Intervention / Treatment
No Intervention: Usual Care
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).
Experimental: Web-based physiotherapy
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS).
Time Frame: Baseline to 6 weeks.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Cincinnati Sports Activity Scale (CSAS)
Time Frame: Baseline to 6 weeks.
CSAS is a patient reported outcome measure, developed to assess the patients' sports participation and identify patients who experience symptoms during athletic activities. It consists of 16 items in 5 separately scored subscales; the frequency of participation, the knee functions that occur during various sports activities and activities of daily living, the change that occurs in activity levels between treatment periods and the problems patients encounter with individual sports that place varying loads on the knee joint. The CSAS is self-reported and takes approximately 6 minutes to complete. The CSAS is reliable, valid and responsive and can be used to evaluate the sports activity levels and participation (Noyes et al., 1989).
Baseline to 6 weeks.
Adherence to exercise programme
Time Frame: Weekly for 6 weeks
Participants are advised to undertake their exercise programme at least once per day for six weeks and adherence will be based on the mean number of completed entries in exercise diaries over the 6 weeks of the programme and the total adherence to the programme will be calculated as a percentage.
Weekly for 6 weeks
Health Resource Form
Time Frame: Week 6
a form detailing the number of interactions with health care professionals, such as physiotherapy and GP visits and medication use during the study.
Week 6

Collaborators and Investigators

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

Sponsor

Glasgow Caledonian University

Collaborators

NHS Greater Glasgow and Clyde

Investigators

  • Principal Investigator: Spiros Nikologiannis, Glasgow Caledonian 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)

June 25, 2018

Primary Completion (Actual)

October 29, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

March 10, 2020

First Submitted That Met QC Criteria

March 12, 2020

First Posted (Actual)

March 16, 2020

Study Record Updates

Last Update Posted (Actual)

March 16, 2020

Last Update Submitted That Met QC Criteria

March 12, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 18/WS/0077

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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