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3D Gait analysis with people with achondroplasia

Organizational Data

DRKS-ID:
DRKS00032557
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2023-08-28
Last update in DRKS:
2024-02-28
Registration type:
Retrospective

Acronym/abbreviation of the study

No Entry

URL of the study

No Entry

Brief summary in lay language

A gait analysis is performed using a motion capturing system (Vicon Nexus) and force plates. First, the subject's body-related data is recorded, questionnaires are answered and four static balance exercises, as well as a jumping exercise, are performed. After that, the subject repeatedly walks a ~10m walking distance. Finally, the test person runs this distance repeatedly.

Brief summary in scientific language

A three-dimensional gait analysis is performed using a motion-capturing system (Vicon Nexus) and force plates embedded in the floor. Beforehand, the anthropometric data of the subject are recorded and questionnaires regarding the quality of life are filled out. Subsequently, a 3D avatar is created in the Vicon system, which reflects the subject. Afterwards, four static, bipedal balance exercises (two each on the floor directly/two with a balance pad) are performed. Subsequently, a countermovement jump is performed with triple repetition. Finally, the gait analysis is performed. Thereby, a ~10m path is repeatedly walked and then ran. To investigate the research objectives, the following parameters are considered: - Kinematic and kinetic gait parameters - balance parameters - Parameters from the questionnaires

Health condition or problem studied

ICD10:
Q77.4 - Achondroplasia
Healthy volunteers:
No

Interventions, Observational Groups

Arm 1:
People with achondroplasia in the age range of 6-18 years. The observation period is 2 1/2 years with half-yearly measurement dates. Follow-up measurements are not planned.
Arm 2:
Typical developed people as control group in the age range of 6-18 years. The observation period is 2 1/2 years with half-yearly measurement dates. Follow-up measurements are not planned.

Endpoints

Primary outcome:
Kinematic and kinetic gait parameters were collected with the ViconNexus system.
Secondary outcome:
Static balance surveyed with AMTI force plates and quality of life assessed by the following questionnaires: - APLES (The Achondroplasia Personal Life Experience Scale). - Qolissy (Quality of life in adolescents of short stature)

Study Design

Purpose:
Basic research/physiological study
Retrospective/prospective:
Prospective
Study type:
Non-interventional
Longitudinal/cross-sectional:
Longitudinal study
Study type non-interventional:
Patient Registry

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • University medical center Universitätsklinik Magdeburg Magdeburg

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2023-08-01
Planned study completion date:
2026-01-31
Actual Study Completion Date:
No Entry
Target Sample Size:
150
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
6 Years
Maximum Age:
18 Years
Additional Inclusion Criteria:
Achondroplasia Group: - A parent or legal guardian who signs the consent form and the subjects information for the subject. - Clinical diagnosis of achondroplasia by the Faculty of Medicine/University Hospital A.ö.R. (FME/UKMD) University Children's Hospital (KPAE) (Dr. Palm) - An age between 6 to 18 years - The ability to walk barefoot independently without an assistive device - Current medical treatment of e.g. vosoritides, orthopedic interventions) or human growth hormones or other medical products that have the intention of influencing body size or body disproportions will be documented at all time points Control group: - A parent or legal guardian who will sign the informed consent form and subject information form for the subject - The ability to follow the test protocol as judged by a member of the measurement team. - An age between 6 to 18 years - Corrected or near normal corrected vision

Exclusion Criteria

Achondroplasia Group: - Skeletal dysplasias other than achondroplasia or medical conditions resulting in decreased body size or abnormal bone growth - Dependence on orthotics or assistive devices for locomotion - Hemieepophysiodesis (< 3 months) - Lengthening of extremities/ osteotomy with full recovery are included with a minimum healing time of 12 months - Past or present injury or disease to the growth plate(s), other than ACH, that affects the growth potential of the bones - Decompression of the foramen magnum and a laminectomy with a complete recovery are allowed with a minimum healing time of 6 months. Control group: - Past lower extremity injuries within the last six months that required medical treatment. - Past orthopedic treatments - History of toe walking - Any foot deformities that required conservative or invasive treatment in the past - Any evidence of neurological abnormalities - Suspected or diagnosed developmental coordinative disorders - Chronic cardio-vascular disease

Addresses

Primary Sponsor

Otto-von-Guericke-Universität Magdeburg, Institut III
Prof. Dr. Kerstin Witte
Postfach 4120
39016 Magdeburg
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Otto-von-Guericke-Universität Magdeburg, Institut III
Prof. Dr. Kerstin Witte
Postfach 41 20
39016 Magdeburg
Germany
Telephone:
+40 391 67 54743
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Otto-von-Guericke-Universität Magdeburg, Institut III
Prof. Dr. Kerstin Witte
Postfach 41 20
39016 Magdeburg
Germany
Telephone:
+40 391 67 54743
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Otto-von-Guericke-Universität Magdeburg, Institut III
Prof. Dr. Kerstin Witte
Postfach 41 20
39016 Magdeburg
Germany
Telephone:
+40 391 67 54743
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Private sponsorship (foundations, study societies, etc.)

Otto-von-Guericke-Universität, Institut III (Graduiertenstipendium / Scholarship for PhD students)
39016 Magdeburg
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethik-Kommission der Otto-von-Guericke-Universität an der Medizinischen Fakultät und am Universitätsklinikum Magdeburg A.ö.R.
Leipziger Str. 44 Haus 28
39120 Magdeburg
Germany
Telephone:
+49-391-6714314
Fax:
No Entry
Contact per E-Mail
URL:
http://www.ethikkommission.ovgu.de/

Vote of leading Ethics Committee

Date of ethics committee application:
2023-06-14
Ethics committee number:
82/23
Vote of the Ethics Committee:
Approved
Date of the vote:
2023-07-20

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry