Individualised Gait Modification Strategies in Alkaptonuria Patients

NCT ID: NCT04142671

Last Updated: 2021-02-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-31
• Study Completion Date: 2022-10-31

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.

Conditions

Alkaptonuria

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Individualised gait modification intervention

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Liverpool University Hospitals NHS Foundation Trust

OTHER_GOV

Sponsor Role: collaborator

Liverpool John Moores University

OTHER

Sponsor Role: lead

Responsible Party

Hannah Shepherd

Associate Lecturer in Clinical Biomechanics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gabor J Barton, MD, PhD

Role: STUDY_DIRECTOR

Liverpool John Moores University

Central Contacts

Hannah H Shepherd

Role: CONTACT

H.R.Shepherd@ljmu.ac.uk

+447711490847

References

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.

Reference Type: BACKGROUND

PMID: 20981808 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22127706 (View on PubMed)

Other Identifiers

248641

Identifier Type: OTHER

Identifier Source: secondary_id

19LJMUSPONSOR086

Identifier Type: -

Identifier Source: org_study_id