Monocenter Interventional Study: Providing Sitting Balance Training With a Newly Developed Rehabilitation Device in the Chronic Stage After Stroke A Feasibility and Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Recruitment
研究概览
简要总结
This clinical study is being conducted to evaluate a new training device, the T-CHAIR, for trunk rehabilitation and post-stroke balance. The investigators would like to study three objectives. First, the investigators want to examine whether training with a new training device is feasible and safe during rehabilitation in the later phase, more than six months after a stroke. The investigators also evaluate whether training with a new training device has an effect on the sitting balance and the function and strength of the trunk. Finally, the investigators examine whether training with a new training device has an effect on walking, standing and activities of daily life and self-care.
详细描述
The primary goal of this study is to evaluate safety, acceptance and feasibility when participants in the chronic phase after a stroke train with this newly developed trainings device. Secondly, the investigators will evaluate the effect of training with this device on secondary outcome parameters such as trunk function, standing and sitting balance, gait and selective movement. The investigators compare the effect on secondary outcomes of the experimental intervention with a control intervention using a randomized controlled trial. Both groups include participants in the chronic phase post-stroke.
TRIAL OBJECTIVES AND PURPOSE
The primary objective of the proposed project is to investigate the feasibility and safety of sitting balance training on the T-chair, in the chronic phase (>6 months) after stroke.
The second objective of the study is to investigate if utilizing the T-chair has an effect on sitting balance, trunk function and trunk strength in participants post stroke, in comparison to conventional therapy.
Thirdly, the investigators will examine if training on the T-chair has an effect on other parameters, such as gait, balance, activities of daily living and reintegration in community.
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 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First major stroke event, a transient ischemic attack or a previous stroke with full recovery is allowed.
- •Impairment of the trunk function, with a maximum score of 19 on the trunk impairment scale .
- •Able to maintain seated position for more than 10 seconds.
- •Able to come to the rehabilitation ward as a chronic patient.
- •More than six months after a stroke event.
- •Older than 18 years.
- •With no comorbidities other than stroke affecting trunk function. Comorbidities could be musculoskeletal problems or other neurological diseases.
- •With sufficient cognitive and language capacity to perform the assessment.
排除标准
- •Not able to give informed consent.
- •Not approved informed consent.
- •Subject does not understand the study procedures.
- •Subject has any history of another major neurological disorder.
结局指标
主要结局
Recruitment
时间窗: Through study completion, an average of 1.5 months.
Recruitment is characterized by the number of possible participants divided by the number of participants actually participated in the trial.
Participation
时间窗: Through study completion, an average of 1.5 months.
During each therapy the therapist evaluates the participation of each candidate.
Safety and Adverse events
时间窗: Through study completion, an average of 1.5 months.
Safety is evaluated by retaining all adverse events during the therapy sessions.
Retention
时间窗: Through study completion, an average of 1.5 months.
Retention is the number of participants that complete the whole trial divided by the number of participants that are included in the study.
Device development or modifications
时间窗: Through study completion, an average of 1.5 months.
Feedback from the participants and therapists to improve the device are noted after every session. Each patient and therapist who came in contact with the device received an experience questionnaire. The questionnaire contains 16 questions, 3 questions and 13 categorical questions on 5 or 7 point Likert scale.
Fatigue
时间窗: Through study completion, an average of 1.5 months.
After each training session fatigue will be evaluated using Visual Analog Fatigue Scale.This scale consists of a 10 cm horizontal line with written description at each end of the line. The written description varies from no fatigue to Very Severe Fatigue on top of the 10 cm line.
Adherence
时间窗: Through study completion, an average of 1.5 months.
After each therapy session the therapist evaluates the adherence using the Clinician Rating of Compliance Scale. This is a seven point ordinal scale which assesses the level of adherence of the patient. A higher score represent better adherence. A score lower than five is defined as non-adherent.
Patient Global Impression of Change
时间窗: Through study completion, an average of 1.5 months.
The patient Global impression of change is a one single question to rate their condition after the therapy sessions compared to the rate of their condition at the start of the therapy session. This scale will be evaluated twice. One time after two weeks of intervention and once after the four weeks of intervention.
Acceptability and enjoyment
时间窗: Through study completion, an average of 1.5 months.
The level of enjoyment during the training will be assessed using the physical activity enjoyment scale. This scale contains 18 items, during the training participants have to score how they feel about the training on a seven-point bipolar scale. The lowest score stands for less enjoyment or acceptance, a higher score stands for maximum enjoyment or acceptance.
次要结局
- Selective movements of the lower extremities and coordination(Through study completion, an average of 1.5 months.)
- Sitting balance(Through study completion, an average of 1.5 months.)
- Walking speed(Through study completion, an average of 1.5 months.)
- Walking capacity(Through study completion, an average of 1.5 months.)
- Trunk stability(Through study completion, an average of 1.5 months.)
- Walking endurance(Through study completion, an average of 1.5 months.)
- Number of falls(Through study completion, an average of 1.5 months.)
- Trunk function(Through study completion, an average of 1.5 months.)
- Trunk strength(Through study completion, an average of 1.5 months.)
- Lower extremities strength(Through study completion, an average of 1.5 months.)
- Balance(Through study completion, an average of 1.5 months.)