Individualised Gait Modification Strategies in Alkaptonuria Patients

Determining Individualised Gait Modification Strategies to Reduce Knee Joint Moments in Alkaptonuria Patients Using Real-time Feedback

This study evaluates the efficacy of a gait modification intervention using real-time biofeedback on reducing the knee joint loading in Alkaptonuria patients during treadmill walking. It will also assess whether the individualised adopted gait modification can be retained without feedback and during over ground walking.

Study Overview

• Status: Not yet recruiting
• Conditions: Alkaptonuria
• Intervention / Treatment: Other: Individualised gait modification intervention

Detailed Description

Alkaptonuria (AKU) is a degenerative disease affecting the cartilage of the joints. The disease affects movement function, particularly walking/gait which is an important activity of daily living. It is believed that increased joint loading measured by the moments acting upon the joints, contributes to the degeneration of joint cartilage in Alkaptonuria, particularly in the weight bearing joints such as the knee and hips, resulting in accelerated progression of painful symptoms. Currently there is no cure for Alkaptonuria and the current management includes joint replacement surgery. Gait modification strategy interventions could be a non-invasive alternative which could delay the time to surgical interventions by reducing or altering joint loading and stalling the progression of disease.

The aims of this study are 1) to determine if individualised gait modification strategies can be used to reduce the 3D knee joint loading, 2) to determine if the gait modifications can be retained without feedback during over ground walking and 3) to determine the individualised gait modification strategies adopted by AKU patients.

Gait data will be measured and quantified using the non-invasive typical clinical gait analysis set up, using 3D motion capture combined with force data whereby joint angles, moments and powers can be calculated in all 3 planes of motion during treadmill walking. The intervention will involve real-time biofeedback using Motek's M-Gait treadmill. Due to the heterogeneity of the sample, each AKU patient will act as their own control. Gait data will be compared pre- and post-intervention and a validated pain score will be used to identify any patterns with knee pain and adopted gait modifications.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hannah H Shepherd; Phone Number: +447711490847; Email: H.R.Shepherd@ljmu.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The diagnosis of Alkaptonuria
• Able to understand written and spoken English.
• Willing and able to give informed consent to participate
• Above the age of 18.

Exclusion Criteria:

• The reliance on or use of a walking aid.
• Any previous lower limb joint replacements.
• Any severe pain or unable to walk comfortably and consecutively for 20 minutes.
• Pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Individualised Gait Modification Intervention; Patients will carry out several walking trials to test the efficacy of an individualised gait modification intervention. Pre-intervention over ground walking, pre-intervention treadmill walking, intervention treadmill walking with real-time biofeedback on their knee loading, intervention treadmill walking with no feedback, and post-intervention over ground walking.

Other: Individualised gait modification intervention; An individualised gait modification intervention to reduce knee joint loading. Knee joint loading will be presented in real-time during treadmill walking. A 10% reduction of each patients baseline knee loading will be used as a target threshold along with visualisation of the history of 5 previous steps. Patients are encouraged to determine their own gait modification strategy that is most efficient for them. Previous examples of gait modifications that mechanically reduce knee loading will be presented to them.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline 3D knee joint moment impulse after intervention	This represents the knee joint load during walking measured from kinematic and kinetic data obtained during the 3D gait analysis	At baseline and immediately after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline joint angles after intervention	Lower limb joint angles in degrees measured from kinematic data obtained during the 3D gait analysis	At baseline and immediately after the intervention
Change from baseline joint moments after intervention	Lower limb joint moments in Nm/kg measured from kinematic and kinetic data obtained during the 3D gait analysis	At baseline and immediately after the intervention
Change from baseline joint powers after intervention	Lower limb joint powers in Watts/kg measured from kinematic and kinetic data obtained during the 3D gait analysis	At baseline and immediately after the intervention
Knee injury and Osteoarthritis Outcome Score	Validated Knee injury and Osteoarthritis Outcome Score Questionnaire. Scores between 0-100, 0 representing extreme problems and 100 representing no problems.	Pre-intervention

Collaborators and Investigators

• Sponsor: Liverpool John Moores University
• Collaborators: Liverpool University Hospitals NHS Foundation Trust
• Investigators: Study Director: Gabor J Barton, MD, PhD, Liverpool John Moores University

Publications and helpful links

General Publications

• Simic M, Hinman RS, Wrigley TV, Bennell KL, Hunt MA. Gait modification strategies for altering medial knee joint load: a systematic review. Arthritis Care Res (Hoboken). 2011 Mar;63(3):405-26. doi: 10.1002/acr.20380. Epub 2010 Oct 27.
• Taylor AM, Boyde A, Wilson PJ, Jarvis JC, Davidson JS, Hunt JA, Ranganath LR, Gallagher JA. The role of calcified cartilage and subchondral bone in the initiation and progression of ochronotic arthropathy in alkaptonuria. Arthritis Rheum. 2011 Dec;63(12):3887-96. doi: 10.1002/art.30606.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2021
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: October 24, 2019
• First Submitted That Met QC Criteria: October 25, 2019
• First Posted (Actual): October 29, 2019

Study Record Updates

• Last Update Posted (Actual): February 26, 2021
• Last Update Submitted That Met QC Criteria: February 25, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Genetic Diseases, Inborn; Metabolism, Inborn Errors; Amino Acid Metabolism, Inborn Errors; Alkaptonuria; Ochronosis
• Other Study ID Numbers: 19LJMUSPONSOR086; 248641 (Other Identifier: IRAS Project ID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual participant data will not be shared with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No