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临床试验/NCT03114046
NCT03114046已完成不适用

Constraint-induced Movement Therapy to Improve Gait and Mobility of People With Chronic Stroke

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2017年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
2
主要终点
Lower Extremity Motor Activity Log (LE-MAL)

研究概览

简要总结

The purpose of this single-subject, concurrent mixed methods study is to investigate the relationship between the effect of the CIMT protocol on gait and mobility and participants' and caregivers' expectations and perceptions regarding the treatment. The goal of the quantitative strand is to assess changes in quality of movement and functional use of the paretic lower limb after the treatment and investigate the participants' expectations in regards the intervention using the Participant Opinion Survey (POS). The qualitative strand (participant interviews) will determine perspectives of caregiver and participant perspectives regarding protocol acceptability. Both quantitative and qualitative data will be collected and analyzed concurrently, through triangulation and complementarity rationales; both data will be equally prioritized.

详细描述

About 66% of stroke survivors present gait impairment and mobility limitation. Rehabilitation techniques for people with walking and mobility disability after stroke have been broadly investigated in recent decades. However, few rehabilitation approaches have been shown to be effective in resolving these devastating problem.

Constraint-induced Movement Therapy (CIMT) presented robust evidence on increasing the amount and the quality of the paretic upper extremity (UE) functional use in daily situations of individuals with brain injuries (e.g. stroke, traumatic brain injury). The UE CIMT protocol consists of 4 components: 1) repetitive and intensive training; 2) motor training following shaping principles; 3) application of a groups of behavioral strategies called transfer package (TP), and 4) prolonged use of a restriction device on the non-paretic (or less affected) UE.

Considering the importance of repetition, intensity and specificity of the motor training to induce neuroplastic changes (3), CIMT is a potential tool to improve gait and mobility function in people with stroke. The translation of the UE protocol for Lower Extremity (LE) rehabilitation demanded some modifications for use with gait and mobility. For example, restraint of the less affected LE is not used because a different gait pattern would be induced using the restriction device. Also, the TP has been modified for LE function because of its inherent differences from UE function (e.g. both LE are more often used together and because there are more safety consequences involved with gait and mobility (e.g. falling).

In view of the significant efficacy of the UE CIMT for individuals with stroke, the extension of this approach to LE CIMT is promising, but investigation of its effect on mobility and motor function has been insufficient. The few studies that have applied a modified CIMT protocol in people with stroke did not use the full TP component. Thus, information about the effects of the complete CIMT protocol (i.e., including the TP) is greatly need. The addition of the enhanced TP in the LE protocol might have a great impact on both motor outcomes and retention of the results, as observed in previous studies about the UE approach. Considering the high intensity of the complete protocol, the added safety concerns, and the demand of involvement of the therapist, participant, and caregivers, the acceptability of the TP should be explored in order to provide a better understanding of the feasibility of this strategy.

The purpose of this single-subject, concurrent mixed methods study is to investigate the relationship between the effect of the CIMT protocol on gait and mobility and participants' and caregivers' expectations and perceptions regarding the treatment (e.g. intensity, physical and emotional demands, changes in routine). The goal of the quantitative strand is to assess changes in quality of movement and functional use of the paretic lower limb after the treatment and to investigate the participants' expectations in regards the intervention using the Participant Opinion Survey (POS). The qualitative strand (participant interviews) will determine perspectives of caregiver and participant perspectives regarding protocol acceptability. Both quantitative and qualitative data will be collected and analyzed concurrently, through triangulation and complementarity rationales; both data will be equally prioritized (4). We hypothesize that: 1) the enhanced LE CIT protocol will be effective for improving functional use of the paretic LE in people with chronic stroke; and 2) participant's and caregivers opinions are related to changes on functional use.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • be 19 years old or older,
  • have more than 6 months after stroke;
  • present motor impairment on lower extremity due to stroke, but able to walk at least 25 feet using an assistive device or not, at least three times a day;
  • have no previous experience with any LE CIMT protocol.

排除标准

  • presence of uncontrolled clinical conditions;
  • presence of other neurologic diseases;
  • Mini-mental State Examination score <24
  • inability to answer yes and no questions properly;
  • score lower than 45 out of 56 on the Berg Balance Scale, and score higher than 5 on LEMAL, what indicates that they are already utilizing the paretic lower limb while performing daily activities.

结局指标

主要结局

Lower Extremity Motor Activity Log (LE-MAL)

时间窗: The LE-MAL will be administered 10 times along 4 weeks. During the first 2 weeks (baseline phase) the stability of the functional use of the paretic lower extremity will be assessed. The last 2 weeks (intervention) the trend of change will be assessed.

is a semi-structured interview, created in the UAB CIMT laboratory, that consists of asks the participant the level of assistance, how well is her/his performance, and how much confident he/she is during the execution of 14 different daily tasks (e.g walking indoors, climb stairs) (6).

Berg Balance Scale (BBS)

时间窗: The BBS will be administered 10 times along 4 weeks. During the first 2 weeks (baseline phase) the stability of balance will be assessed. The last 2 weeks (intervention) the trend of change will be assessed.

is a valid and reliable tool to assess balance control in 14 static and dynamic activities with people with different health conditions (7).

10 meters walking (10MWT)

时间窗: The 10MWT will be administered 10 times along 4 weeks. During the first 2 weeks (baseline phase) the stability of the gait function will be assessed. The last 2 weeks (intervention) the trend of change will be assessed.

is a gait speed measurement, which is an easy and reliable assessment of locomotion (8).

次要结局

  • Life-Space Assessment (LSA).(The test will be administered 10 times along 4 weeks. During the first 2 weeks (baseline phase) the stability of the mobility status will be assessed. The last 2 weeks (intervention) the trend of change will be assessed.)
  • 5 times sit to stand(The test will be administered 10 times along 4 weeks. During the first 2 weeks (baseline phase) the stability of the lower limb function will be assessed. The last 2 weeks (intervention) the trend of change will be assessed.)
  • 6 minutes walking test (6MWT)(The 6MWT will be administered 10 times along 4 weeks. During the first 2 weeks (baseline phase) the stability of the gait function will be assessed. The last 2 weeks (intervention) the trend of change will be assessed.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sarah Monteiro Dos Anjos, PhD

Principal Investigator

University of Alabama at Birmingham

研究点 (2)

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