Bone Sarcoma Clinical Trial
— proGAITOfficial title:
3D Gait Analysis to Determine Functional Limitations and Evaluate a Training Intervention in Young People With Tumor Endoprosthesis of the Lower Extremity
Verified date | November 2022 |
Source | Universität Duisburg-Essen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The proGait-study is a two-arm exercise intervention study for AYA-patients with lower extremity tumor endoprosthesis in the follow-up care. This clinical trial will investigate the effects of an 8-week personalized multi-modal exercise intervention of lower extremity muscles on gait quality in adolescents and young adults with cancer diagnosis beginning at least 12 months after endoprosthesis implantation.
Status | Completed |
Enrollment | 11 |
Est. completion date | May 1, 2022 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years to 45 Years |
Eligibility | Inclusion Criteria: - Adolescents and young adults between 15 and 45 years of age - Completion of acute cancer treatment and receiving follow-up care in Essen (University Hospital Essen) - At least 12 months post endoprosthesis implantation - Signed informed consent (Parents and Patient) Exclusion Criteria: - <15 years of age, >45 years of age - time post implantation <12 months - Medical condition that limits participation in one of the study arms - Inability to follow the training-protocol |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital Essen | Essen | NRW |
Lead Sponsor | Collaborator |
---|---|
Universität Duisburg-Essen | Ruhr University of Bochum |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Gait Profile Score | Marker based 3D gait analysis is performed on a 15m runway and recorded at 120Hz with 8 cameras from different projection angles around the runway (Vicon, Oxford, UK). Gait Profile Score is based on the averaged RMS differences in lower body kinematics (Pelvis tilt ant/post, Pelvis tilt up/down, Pelvis internal rotation/external rotation, Hip joint flexion/extension, Hip joint adduction/abduction, Hip joint internal rotation/external rotation, Knee flexion/extension, Ankle joint Dorsiflexion/Plantarflexion, Foot opening angle Internal rotation/External rotation) of subjects and kinematic reference data from a healthy population during a time normalized gait cycle. A lower GPS would indicate less deviation from a healthy populations gait pattern and thus indicate a better outcome. | 8 weeks | |
Secondary | Functional Mobility | Functional Mobility Assessment score (points, score range 0 - 70, higher score = better outcome) between both study arms from T0 to T1 | 8 weeks | |
Secondary | Subjective functional outcome | Change in Musculoskeletal Tumor Society Score (questionnaire score, score range 0 - 30, higher score = better outcome) between both study arms | 8 weeks | |
Secondary | Subjective functional measure | Change in Toronto Extremity Salvage Score(questionnaire score, score range 0 - 100, higher score = better outcome) between both study arms | 8 weeks | |
Secondary | Subjective Quality of Life Adults | Change in Quality of Life (QLQ-C30 questionnaire score from 0 - 100) between both study arms | 8 weeks | |
Secondary | Subjective Quality of Life Adolescents | Change in Quality of Life (PedsQL cancer module, questionnaire score from 0 - 100) between both study arms | 8 weeks | |
Secondary | Fatigue Adults | Change in Fatigue (EORTC QLQ Fatigue questionnaire range 0 - 100, higher score = worse outcome) between both study arms | 8 weeks | |
Secondary | Range of motion | Change in affected knee range of motion (angular degree °) assessed with goniometry between both study arms | 8 weeks | |
Secondary | Gait kinematics | Changes in lower body gait kinematics between both study arms from T0 to T1 by assessing the Gait Deviation Index (GDI), measure of difference between subjects and a healthy control dataset of lower body kinematics. A GDI of 100 indicates a subject whose gait is at least as close to the healthy average as that of a randomly selected healthy individual. Thus, a GDI of 100 or higher indicates the absence of gait pathology. Every 10 points that the GDI falls below 100 corresponds one standard deviation away from the healthy populations mean. | 8 weeks | |
Secondary | Fatigue Adolescents | Change in Fatigue (PedsQL fatigue questionnaire score, range 0 - 100, higher score = worse outcome) | 8 weeks |
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