跳至主要内容
临床试验/NCT05925673
NCT05925673Unknown不适用

Early Neuromuscular Stimulation and Mirror Therapy Interventions During Immobilization of Distal Radius Fracture

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2024年2月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
72
试验地点
2
主要终点
Adherence

研究概览

简要总结

Current practice for distal radius fractures is to begin rehabilitation after immobilization to remediate the resulting impairments. Neuromuscular electrical stimulation and mirror therapy are strategies that integrate neurological and musculoskeletal activation, that may be beneficial for mitigating the resulting impairments if applied during immobilization. The study aim is to determine whether neuromuscular stimulation and mirror therapy interventions can be implemented during immobilization for distal radius fractures to minimize the resulting impairments when compared to standard rehabilitation.

详细描述

Distal radius fractures are one of the most common orthopedic injuries require 6 to 8 weeks of immobilization for bone healing making it an ideal model to evaluate the negative consequences of immobilization. Consequences of immobilization include motor dysfunction (e.g. muscular atrophy), loss of the representation of motor and sensory function, and loss of fine motor skills. Current practice is to begin rehabilitation after immobilization to remediate these impairments. Neuromuscular electrical stimulation and mirror therapy are strategies that integrate neurological and musculoskeletal functioning, that can be used during immobilization to mitigate negative consequences. To date, these strategies have primarily been implemented in stroke rehabilitation, but minimal research has been done to assess their effectiveness with musculoskeletal populations. The study aim is to determine whether neuromuscular stimulation and mirror therapy interventions can be implemented during immobilization for distal radius fractures to minimize impairments when compared to standard rehabilitation. Four groups will be compared: group 1 will engage in standard care, group 2 will engage in a mirror therapy intervention during immobilization, group 3 will engage in a neuromuscular stimulation intervention during immobilization, and group 4 will engage in a combined mirror therapy + neuromuscular stimulation intervention during immobilization. Patient reported and objective outcome measures will be assessed at baseline (before starting intervention; 3 weeks), after cast removal and completion of the intervention (6 weeks), 8 (to 10) weeks, and 12 weeks post fracture. Ideally these interventions will improve outcomes and facilitate rehabilitation after distal radius fracture which could allow patients to return to their daily activities and work more readily after fracture.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Sustained a distal radius fracture in the last 3 weeks being managed conservatively in a cast
  • Able to understand instructions in English
  • Able to give informed consent (no known cognitive impairment that would limit this)

排除标准

  • Cognitive disorders that would preclude the participant from following instructions and engaging in the home interventions
  • Visual impairments that limit ability to engage in NMES and mirror therapy interventions
  • Superficial metal implants in the injured arm
  • Cancer (active)
  • Severe peripheral vascular disease
  • Thrombophlebitis in injured arm

研究组 & 干预措施

Standard of Care

No Intervention

Participants will follow standard practice protocols at the Roth McFarlane Hand and Upper Limb Centre in London.

Mirror Therapy

Experimental

Participants will engage in a home based mirror therapy intervention from 3 to 6 weeks post-fracture.

干预措施: Mirror Therapy (Other)

Neuromuscular Stimulation (NMES)

Experimental

Participants will engage in a home based neuromuscular stimulation intervention from 3 to 6 weeks post-fracture.

干预措施: Neuromuscular Stimulation (NMES) (Other)

Mirror Therapy + NMES

Experimental

Participants will engage in a home based combined mirror therapy + neuromuscular stimulation intervention from 3 to 6 weeks post-fracture.

干预措施: Mirror Therapy + NMES (Other)

结局指标

主要结局

Adherence

时间窗: 6 weeks post fracture

% of sessions completed

次要结局

  • EuroQol-5D (EQ-5D)(Baseline, 6, 8 to 10, and 12 weeks post fracture)
  • Global Rating of Change (GRC)(Baseline, 6, 8 to 10, and 12 weeks post fracture)
  • Numeric Pain Rating Scale (NPRS) at rest(Baseline, 6, 8 to 10, and 12 weeks post fracture)
  • Single Assessment Numeric Evaluation (SANE)(Baseline, 6, 8 to 10, and 12 weeks post fracture)
  • Range of motion (ROM) - affected side(6, 8 to 10, and 12 weeks post fracture)
  • Pinch Strength - unaffected side(Baseline, 6, 8 to 10, and 12 weeks post fracture)
  • Electromyography (EMG)(8 to 10 and 12 weeks post fracture)
  • Patient-Rated Wrist Evaluation (PRWE)(Baseline, 6, 8 to 10, and 12 weeks post fracture)
  • Vividness of Movement Imagery Questionnaire-2 (VIMQ-2)(Baseline, 8 to 10, and 12 weeks post fracture)
  • Range of motion (ROM) - unaffected side(Baseline, 6, 8 to 10, and 12 weeks post fracture)
  • Dexterity(Baseline, 6, 8, 10, and 12 weeks post fracture)
  • Pinch Strength - affected side(8 to 10, and 12 weeks post fracture)
  • Grip Strength - unaffected side(Baseline, 6, 8 to 10, and 12 weeks post fracture)
  • Grip Strength - affected side(8 to 10, and 12 weeks post fracture)
  • Numeric Pain Rating Scale (NPRS) during movement(Baseline, 6, 8 to 10, and 12 weeks post fracture)

研究者

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

Joy MacDermid

Professor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

研究点 (2)

Loading locations...

相似试验