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临床试验/NCT06910904
NCT06910904已完成不适用

CONSTRAINT-INDUCED MOVEMENT THERAPY (CIMT) VS. MIRROR THERAPY (MT) ON HAND FUNCTION AND SPASTICITY IN PATIENTS WITH HEMIPARESIS

University of Lahore2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2024年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
68
试验地点
2
主要终点
Motor impairment and and joint functioning

研究概览

简要总结

This study aimed to compare the effects of Constraint-Induced Movement Therapy (CIMT) and Mirror Therapy (MT) on hand function and spasticity in individuals with hemiparesis. A total of 68 participants diagnosed with hemiparesis due to stroke or traumatic brain injury were recruited and randomly assigned to two equal groups. Group A received CIMT, while Group B underwent Mirror Therapy. Both interventions were administered over an 8-week period in a controlled rehabilitation setting. Functional assessments were conducted using the Fugl-Meyer Assessment for Upper Extremity (FMA-UE) to evaluate motor function and the Modified Ashworth Scale (MAS) to measure spasticity. Data collection occurred at baseline, the 4th week, and the 8th week of the intervention. Descriptive statistics were used to summarize demographic characteristics and baseline measurements, while inferential statistics, including repeated-measures ANOVA and independent t-tests, were applied to assess within- and between-group changes over time. The study also ensured assumptions of normality and sphericity were met to validate the statistical analyses. Demographic data such as age, gender, diagnosis type, and education level were also recorded to understand group comparability and potential influences on therapy outcomes. This study adds to the growing body of literature on non-invasive, evidence-based rehabilitation strategies for upper limb recovery.

详细描述

Hemiparesis, often resulting from conditions such as stroke or traumatic brain injury (TBI), leads to significant impairment in upper limb function and increased spasticity, adversely affecting daily living activities and overall quality of life. Rehabilitation strategies focusing on motor relearning, functional task training, and neuroplastic adaptation are crucial for regaining voluntary control and independence. Among the numerous interventions available, Constraint-Induced Movement Therapy (CIMT) and Mirror Therapy (MT) have emerged as two widely researched and clinically applied neurorehabilitation techniques targeting motor recovery in patients with hemiparesis.

Constraint-Induced Movement Therapy is based on the principle of "learned non-use," where the unaffected limb is restricted to encourage active use of the affected limb through repetitive, task-specific training. This therapy stimulates cortical reorganization and promotes motor recovery by intensively engaging the paretic limb. In contrast, Mirror Therapy involves the use of a mirror placed in the patient's midline to reflect movements of the unaffected limb, creating a visual illusion that the affected limb is functioning normally. This visual feedback mechanism is believed to activate mirror neurons and support motor relearning through sensory-motor integration.

This study was designed to compare the efficacy of CIMT and Mirror Therapy on improving hand function and reducing spasticity in patients with hemiparesis. The purpose was to determine whether one intervention offers superior functional outcomes or if both are equally beneficial, thereby informing evidence-based rehabilitation practices. A randomized, two-group design was employed to ensure balanced distribution and comparability between the intervention arms.

A total of 68 participants diagnosed with hemiparesis due to either ischemic stroke, hemorrhagic stroke, or traumatic brain injury were recruited from a rehabilitation center. Inclusion criteria involved patients aged 40-65 years with unilateral upper limb paresis, preserved cognitive function to follow instructions, and the ability to participate in scheduled therapy sessions. Exclusion criteria included individuals with severe cognitive deficits, unhealed fractures, or other orthopedic conditions that could interfere with upper limb training.

Participants were randomly allocated into two groups: Group A received Constraint-Induced Movement Therapy and Group B received Mirror Therapy. Both interventions were carried out over an 8-week period with standardized protocols. CIMT participants wore a mitt or sling on their unaffected limb for several hours each day during therapy to force usage of the affected arm in performing guided, functional tasks. Mirror Therapy participants performed symmetrical bilateral movements while focusing on the reflection of their unaffected arm in the mirror, tricking the brain into perceiving normal movement in the paretic limb.

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)

盲法说明

In this study, a single-blind design was implemented where the outcome assessors were masked to group allocation to reduce assessment bias. Participants and therapists delivering the interventions were not masked due to the nature of the therapies, which required active participation and visible techniques. Data analysts were also blinded to group identities during statistical processing to maintain objectivity. No additional parties beyond assessors and analysts were involved in masking.

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants having age (between 40 and 65 years old) will be recruited.
  • Both gender were included (e Silva et al., 2017).
  • Participants having ability to follow verbal and visual instructions (Danlami & Abdullahi, 2017).
  • Patient having hemiparesis from 14 to 90 days (Bastola et al., 2021).
  • Patients with mild to moderate spasticity (Burnstrom stage 2) (Jan et al., 2019).
  • Patients experiencing functional limitations in hand motor function (Gracies et al., 2019).

排除标准

  • History of other neurological conditions (Mansfield et al., 2018).
  • Unstable fracture or other orthopedic conditions (Page et al., 2007).
  • Individuals with physical limitations that prevent them from positioning themselves adequately to view their affected limb in the mirror during therapy sessions, as this could compromise the effectiveness of mirror therapy (Danlami & Abdullahi, 2017).
  • History of shoulder instability or major orthopedic surgery in the affected arm (Gracies et al., 2019).

结局指标

主要结局

Motor impairment and and joint functioning

时间窗: Baseline, Week 4, and Week 8

Assessed using the Fugl-Meyer Assessment for Upper Extremity (FMA-UE), which measures motor function, coordination, and reflex activity in the affected limb to evaluate improvements in voluntary movement.

次要结局

  • Spasticity(Baseline, Week 4, and Week 8)

研究者

发起方
University of Lahore
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mahnoor Aleem

Student

University of Lahore

研究点 (2)

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