跳至主要内容
临床试验/NCT05458947
NCT05458947招募中不适用

A Prospective Analysis of Physical Therapy Wound Care Modalities in Patients With Spinal Cord Injury

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年10月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
2
主要终点
Bates-Jensen Wound Assessment Tool (BWAT) score

研究概览

简要总结

To examine the effects of Physical Therapist (PT) wound care modalities (pulsed wound irrigation (PWI) + electrical stimulation (ES), PWI only, and ES only) on wound healing in patients with spinal cord injuries (SCI).

详细描述

It is hypothesized that PWI + ES will demonstrate the greatest rate of wound healing due to the combined effect of these treatments, which positively impact several aspects of the wound healing cascade. It is hypothesized that all patients will demonstrate improved quality of life from receiving wound care treatments by Physical Therapists due to individualized education and treatments which engage patients in their wound healing process and promote self-efficacy.

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
None

入排标准

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

入选标准

  • Currently enrolled at inpatient rehabilitation at Carolinas Rehabilitation Charlotte
  • Diagnosis of spinal cord injury and concomitant pressure injury to sacrum or ischium
  • Agreeable to wound care treatment by Physical Therapist (PT)
  • Able to perform informed consent
  • Over 18 years of age
  • Physician order for PT wound care evaluation and treatment
  • Bates-Jensen Wound Assessment Tool (BWAT) >31 on initial evaluation

排除标准

  • Pain which limits ability to tolerate wound care treatments
  • Unable to perform informed consent
  • Pregnancy
  • Bates-Jensen Wound Assessment Tool (BWAT) <30 on initial evaluation

结局指标

主要结局

Bates-Jensen Wound Assessment Tool (BWAT) score

时间窗: Year 1

15-item objective measure designed to assess wound status and track healing - related to healing on a 1 (healed) to 5 (severe) scale to create a summative score between 13-65 with lower scores indicating progression towards healing

次要结局

  • Change in The Spinal Cord Injury Quality of Life measurement system (SCI-QOL) Short Form Score(Baseline and Year 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验