Stroke Rehabilitation Through Intensive Exercise
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Fugl-Meyer Assessment for the lower extremity (LE-FMA)
研究概览
简要总结
The goal of this clinical trial is to learn whether combining moderate to high intensity aerobic exercise with constraint-induced movement therapy (CI therapy) can improve walking ability in adults who have had a stroke. The study will also learn if telerehabilitation at home can support long-term recovery after intensive rehabilitation.
The main questions this study aims to answer are:
- Does moderate to high intensity aerobic exercise before CI therapy improve walking ability, balance and lower extremity function in people with long-lasting gait difficulties after stroke?
- Does CI therapy alone lead to similar or different improvements in walking ability, balance or lower extremity function?
- Does telerehabilitation help participants maintain or further improve their function after the intensive rehabilitation period?
Researchers will compare two groups. One group will receive 4 weeks of CI therapy, 5 days per week, plus 20 minutes of moderate-to-high-intensity aerobic exercise before the rehabilitation session on 3 of these days, and the other group will receive 4 weeks of CI therapy, 5 days per week, without preparatory aerobic exercise.
After the completion of CI therapy, all participants will be offered an individualized 8-week telerehabilitation program to follow at home. They will use a mobile application to report physical activity and follow instructions for telerehabilitation.
All participants will complete two assessment visits (about 3 hours each), 1-2 weeks before and 1-2 weeks after CI therapy. They will also complete questionnaires electronically after the telerehabilitation program.
Daily activity will be measured twice during the study: once during a week after the intensive rehabilitation and once during a week after the telerehabilitation program. A small movement sensor worn on the thigh will be used. The sensor is attached with a soft strap or an adhesive patch and is comfortable to wear all day. The sensor shows how much a person walks, stands, or sits in everyday life. It is light, does not disturb normal activities, and only collects movement information for the study. An instruction sheet will be included to make it easy to use.
详细描述
This study will use a two-arm, cluster-randomised experimental design to investigate whether lower-extremity modified constraint-induced movement therapy (LE-mCIMT) is more effective when combined with moderate-to-high-intensity aerobic exercise.
A total of 50 stroke survivors will be recruited. All participants will have experienced a stroke at least 6 months earlier and present with persistent gait impairments. Eligible individuals must have been referred for intensive CI therapy at Neurocampus, Sophiahemmet, or at the rehabilitation clinic Furuhöjden in Stockholm, and must have been assessed as medically suitable for intensive training by a responsible physician.
All assessments, baseline and post-intervention, will be conducted at the Laboratory for Applied Sport Science (LTIV) at the Swedish School of Sport and Health Sciences (GIH) in Stockholm, with remote data collection via a digital platform and an activity monitor.
Participants will be allocated to the two intervention arms via cluster randomisation within their rehabilitation cohort. The rehabilitation program is organised in groups of five patients per 4-week block. Eligible participants within the same rehabilitation cohort will be treated as a single cluster to prevent contamination between intervention types. Because members of the same cohort train together daily, share therapists, and interact closely throughout the program, individual randomisation within a cohort could lead to cross-influence and dilution of treatment effects. To avoid this, each rehabilitation cohort (cluster) will be randomised to one of two conditions:
- LE-mCIMT-EXE, consisting of LE-mCIMT combined with moderate-to-high intensity aerobic exercise, or
- LE-mCIMT-TAU, consisting of LE-mCIMT delivered according to standard treatment procedures without additional aerobic exercise.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 70 years.
- •History of a first-ever stroke occurring at least 6 months before enrollment.
- •Independence in personal activities of daily living (e.g., dressing, undressing, and using the toilet).
- •Ability to take a few steps indoors without a walking aid and without supervision; use of an orthosis is permitted.
排除标准
- •Unstable cardiovascular disease or exercise-induced epilepsy.
- •Insufficient cognitive ability to participate in group-based training, including the capacity to understand, follow, and maintain verbal instructions during exercise tasks.
- •Blood pressure >140/90 mmHg at the first visit.
研究组 & 干预措施
LE-mCIMT- EXE
干预措施: LE-mCIMT-EXE (Behavioral)
LE-mCIMT- TAU
干预措施: LE- mCIMT-TAU (Behavioral)
结局指标
主要结局
Fugl-Meyer Assessment for the lower extremity (LE-FMA)
时间窗: From enrollment to the end of the 4 week rehabilitation program
Fugl-Meyer Assessment (FMA) motor recovery.
Stroke Impact Scale (SIS)
时间窗: From start ( after the 4-week rehabilitation program) to the end of the 8 week telerehabilitation program.
SIS reflects the patient's perceived functional improvement and quality of life.
Daily physical activity levels
时间窗: From start ( after the 4-week rehabilitation program) to the end of the 8 week telerehabilitation program.
Daily physical activity levels measured using a thigh worn accelerometry monitor. The physical activity monitors provide quantitative data on daily activity levels in natural environments.
次要结局
- Stroke Impact Scale (SIS)(From enrollment to the end of the 4 week rehabilitation program)
- Mini BESTest(From enrollment to the end of the 4 week rehabilitation program)
- Six minutes walk test(From enrollment to the end of the 4 week rehabilitation program)
- 10-Meter Walk Test (10 mWT)(From enrollment to the end of the 4 week rehabilitation program)
研究者
Maria Ekblom
Professor
The Swedish School of Sport and Health Sciences