Individualised Gait Modification Strategies in Alkaptonuria Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Alkaptonuria

Intervention / Treatment
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* Other: Individualised gait modification intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Single group trial pre- post-intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individualised Gait Modification Intervention<br>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<br>* 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.<br>|

What is the study measuring?
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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 |