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

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.

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

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.
33

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

  • 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

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

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

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.
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

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
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

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
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Glasgow Caledonian University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
NHS Greater Glasgow and Clyde

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

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 25, 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.
October 29, 2018

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.
December 31, 2018

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).
March 10, 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.
March 12, 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.
March 16, 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.
March 16, 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.
March 12, 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.
March 1, 2020

More Information

Terms related to this study

Keywords

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.
  • 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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