Individualised Gait Modification Strategies in Alkaptonuria Patients

Not Applicable

• Conditions: Alkaptonuria
• Interventions: Other: Individualised gait modification intervention

• Registration Number: NCT04142671
• Lead Sponsor: Liverpool John Moores University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2019-10-24
• Study First Submitted QC: 2019-10-25
• Study First Posted: 2019-10-29
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-25
• Last Update Posted: 2021-02-26
• Study Start: 2021-10
• Primary Completion: 2022-10
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Individualised Gait Modification Intervention	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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