Clinical trial NCT04142671: Individualised Gait Modification Strategies in Alkaptonuria Patients
Official title: Determining Individualised Gait Modification Strategies to Reduce Knee Joint Moments in Alkaptonuria Patients Using Real-time Feedback
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alkaptonuria
Lead sponsor: Liverpool John Moores University
Sponsor class: OTHER
Collaborators: name: Liverpool University Hospitals NHS Foundation Trust
First posted: 2019-10-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group trial pre- post-intervention
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline 3D knee joint moment impulse after intervention
timeFrame: At baseline and immediately after the intervention
Secondary outcomes:
measure: Change from baseline joint angles after intervention
timeFrame: At baseline and immediately after the intervention
measure: Change from baseline joint moments after intervention
timeFrame: At baseline and immediately after the intervention
measure: Change from baseline joint powers after intervention
timeFrame: At baseline and immediately after the intervention
measure: Knee injury and Osteoarthritis Outcome Score
timeFrame: Pre-intervention
Other outcomes:
Locations:
Study officials:
affiliation: Liverpool John Moores University
name: Gabor J Barton, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.