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临床试验/NCT06963671
NCT06963671Enrolling By Invitation不适用

What is the Effect of Low-load Blood Flow Restriction Training in the Nonoperative Rehabilitation of Ulnar-sided Wrist Pain?

Stanford University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年8月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
90
试验地点
1
主要终点
Grip Strength

研究概览

简要总结

The purpose of this study is to determine the strength, pain and functional benefits of early, low-load resistance training with blood flow restriction (BFR) in ulnar-sided wrist pain treated nonoperatively with immobilization for 4-6 weeks. Hypothesis: patients in the BFR group with have improved grip strength and patient reported outcome measure scores compared to the control group.

详细描述

Patients presenting to the hand therapy or hand surgery clinic who meet inclusion criteria will be screened, consented, and enrolled. This will include administration of the blood flow restriction screening questionnaire.

Patients with non operatively managed ulnar-sided wrist pain, who have been immobilized for at least 4 weeks 0 days, but no more than 6 weeks 6 days, and are referred to Stanford's Hand Therapy clinic, will receive either standard care or a standard care home program with low-load strengthening under a blood flow restricted (BFR) condition during their therapy sessions. Patients will be assigned to groups in simultaneous enrollment in two arms. The control group will receive standard rehabilitation during therapy visits plus a home program that will be dictated based on the associated phase of rehabilitation. The treatment group will receive standard rehabilitation as a home program plus low-load resistance training with BFR application while at the hand therapy clinic for their appointments, both of which will be dictated based on the associated phase of rehabilitation. Therapists will use the OMNI-Resistance Exercise Scale for Rate of Perceived Exertion Active Muscles (OMNI-RES RPE-AM) to grade all strengthening exercises for each individual in both groups. The target RPE-AM for each exercise will be 7-9 by the last set for resistance exercises in both control and treatment groups.

研究设计

研究类型
干预性
分配方式
非随机
干预模型
序贯
主要目的
治疗
盲法
开放(无盲法)

入排标准

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

入选标准

  • All patients (>18 years) undergoing outpatient rehabilitation at Stanford Hand Therapy
  • English fluency and literacy
  • Able to take informed consent
  • Have acute or chronic ulnar-sided wrist pain referred for a course of hand therapy by a physician or advanced practice provider (APP) and were treated with continuous immobilization for 4-6 weeks.
  • Score of 3 or less on blood flow restriction screening questionnaire

排除标准

  • Concomitant injuries such as upper extremity fractures or other ligamentous injuries
  • TFCC surgery in the affected wrist
  • Non-compliance with immobilization
  • Patients who complete hand therapy at an outside facility
  • Score of 4 or more on blood flow restriction screening questionnaire

研究组 & 干预措施

Blood Flow Restriction

Experimental

The Blood Flow Restriction group will receive BFR treatment

干预措施: Blood Flow Restriction (Behavioral)

Control

No Intervention

The control arm will receive the standard of care treatment for ulnar sided wrist pain

结局指标

主要结局

Grip Strength

时间窗: From enrollment to 6 weeks after initiation of BRF

Grip Strength as measured by a dynamometer in pounds.

次要结局

  • Patient Reported Wrist Evaluation (PRWE)(From enrollment to 6 weeks after initiation of BRF)
  • Patient Reported Wrist Evaluation (PRWE)(From enrollment to 6 weeks after initiation of BRF)

研究者

申办方类型
其他
责任方
主要研究者
主要研究者

Robin Kamal

Associate Professor

Stanford University

研究点 (1)

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标识符

NCT 编号
NCT06963671
其他研究编号
80801

日期

首次提交
(去年)
首次发布
(去年)
主要完成日期
(2年后)
研究完成日期
(2年后)
最近核实
(2个月前)
最近更新
(上个月)

监管与共享

FDA 监管药物
否
FDA 监管器械
否
个体参与者数据共享计划
否
是否有结果
否

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