3D Gait Analysis to Determine Functional Limitations and Evaluate a Training Intervention in Young People with Tumor Endoprosthesis of the Lower Extremity
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Gait Profile Score
研究概览
简要总结
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.
详细描述
The main objective of the proGait-study is to investigate the effects of an 8-week personalized, partially supervised exercise program for lower extremity muscles on gait kinematics of adolescents and young adults, who are in follow-up care after cancer treatment and at least 12 months after endoprosthesis implantation. This randomized controlled trial will include n=20-30 patients. Patients will be randomly assigned to the intervention or control group. Patients in the intervention group will perform two supervised exercise sessions in week one and two. In the following weeks, they will perform in a mix of supervised and unsupervised exercise sessions to introduce the patients into independent exercise. Both groups receive recommendations for individual lower extremity exercise. Secondary aims of this interventional study are to evaluate functional mobility, knee range of motion and patient-reported outcomes including QoL and fatigue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 15 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •<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
研究组 & 干预措施
Exercise therapy
8 weeks personalized, multi-modal exercise with focus on lower extremity
- Initial consultation with recommendations for general physical activity
- Brochure with exercise recommendations
- 2x per week multi-modal group-based and supervised exercise (endurance, strength, mobility, coordination)
- week 1 and 2 supervised, week 3 and 4 partially supervised, week 5 and 6 only one supervised session, week 7 and 8 last two sessions supervised
干预措施: Exercise therapy (Behavioral)
Information group
- Initial consultation with recommendations for general physical activity
- Brochure with exercise recommendations.
干预措施: Information (Other)
结局指标
主要结局
Gait Profile Score
时间窗: 8 weeks
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.
次要结局
- Functional Mobility(8 weeks)
- Subjective functional outcome(8 weeks)
- Subjective functional measure(8 weeks)
- Subjective Quality of Life Adults(8 weeks)
- Subjective Quality of Life Adolescents(8 weeks)
- Fatigue Adults(8 weeks)
- Range of motion(8 weeks)
- Gait kinematics(8 weeks)
- Fatigue Adolescents(8 weeks)
研究者
Miriam Götte
Principal investigator, Head of exercise oncology group
Universität Duisburg-Essen