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Telerehabilitation After Spine Surgery

2026年8月27日 更新者:Kuopio University Hospital

Telerehabilitation as a Method of Rehabilitation Instructions After Spinal Decompression Surgery

The goal of this randomized clinical trial is to assess how different methods of delivering post-operative instructions affect the participants' recovery after spinal decompression surgery. In addition, the investigators evaluate the related healthcare costs and the use of healthcare services in both working-age and elderly populations. The main research questions of the study are:

  1. Does the method or timing of post-operative information influence healthcare utilization or recovery after surgery?
  2. Are telerehabilitation methods easily accessible and usable for the elderly population?
  3. Does early intervention provided in the hospital lead to different recovery times after surgery?

The outcome measures include pain levels, daily activity levels, and healthcare utilization. The results will be compared between study groups based on the information delivery method and age group.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

300

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • Kuopio、芬兰
        • 招聘中
        • Kuopio University Hospital
        • 接触:
        • 副研究员:
          • Jannina Koponen
        • 首席研究员:
          • Janne Pesonen

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • One-level spinal condition requiring decompression surgery
  • Working-age group: 20-65 years; Elderly group 65-85 years
  • Willing to participate

Exclusion Criteria:

  • Malignant disease under active treatment
  • Other disease affecting spine (for example ankylosing disease or vertebral fracture)
  • Opioid or other substance dependancy

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:Working-aged spinal decompression, one-level, ppt
Patient receives physiotherapy personally after surgery while leaving hospital
Physiotherapist gives the patient rehabilitation instructions after surgery when the subject leaves hospital
实验性的:Working-aged spinal decompression, one-level, tele
Patient receives telerehabilitation personally after surgery 5-7 days
Rehabilitation instrucions given by physiotherapist 4-7 days after surgery with remote telerehabilitation method
安慰剂比较:Working-aged spinal decompression, one-level, nurse
Patient receives nurse's instructions personally after surgery while leaving hospital
Nurse gives the patient rehabilitation instructions after surgery when the subject leaves hospital
实验性的:Elderly spinal decompression, one-level, tele
Patient receives telerehabilitation personally after surgery 5-7 days
Rehabilitation instrucions given by physiotherapist 4-7 days after surgery with remote telerehabilitation method
实验性的:Elderly spinal decompression patient, one-level, hpt
Patient receives physiotherapy personally after surgery at hospital outpatient clinic
Physiotherapist gives the patient rehabilitation instructions at the hospital outpatient clinic after 4-7 days post-operatively
有源比较器:Elderly spinal decompression patient, one-level, ppt
Patient receives physiotherapy personally after surgery when leaving the
Physiotherapist gives the patient rehabilitation instructions after surgery when the subject leaves hospital

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Pain after surgery
大体时间:From enrollment to 1 year
Pain level / numerical rating scale, range 0-10 where 0 is no pain and 10 is most severe pain imaginable
From enrollment to 1 year
Function after surgery
大体时间:From enrollment and surgery to 12months after surgery

Function/disability after surgery: investigators assess participants' function and disability by Roland-Morris Disability Questionnaire (RMDQ). RMDQ is a 24-item self-report questionnaire about how low-back pain affects functional activities.

Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability).

From enrollment and surgery to 12months after surgery
Disability after surgery (Oswestry Disability Index, ODI)
大体时间:From enrollment to 12 months after surgery

Oswestry Disability Index (ODI) is a tool used to assess the impact of low back pain on daily functioning. It consists of a questionnaire with 10 questions that evaluate various aspects of daily activities, such as movement, sitting, standing, and sleeping. Each question is scored on a scale from 0 to 5, where 0 indicates no restrictions and 5 indicates significant restrictions. The total score is calculated by summing the scores from the questions, and the higher the score, the greater the impact of the condition on daily life.

Common interpretation ranges include: 0-20 Normal or minimal disability; 21-40 Moderate disability; 41-60 Severe disability; 61-80 Disability that significantly restricts daily activities; 81-100 Bed bound or symptoms may be exaggerated

From enrollment to 12 months after surgery

次要结果测量

结果测量
措施说明
大体时间
Daily activity level after surgery
大体时间:From enrollment to 1 year after operation
Daily amount of steps, as measured with Garmin wearable activity tracker. Investigatos get the steps taken per day from the device as well as activity index measured by the device.
From enrollment to 1 year after operation
Overall health
大体时间:From enrollment to surgery and 12 months post-op
Overall health EuroQol 5D questionnaire: The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: (1) no problems, (2) slight problems, (3) moderate problems, (4) severe problems and (5) extreme problems. Each category is measured by above levels independently. The 5 dimensions' points do not combine as a sum score.
From enrollment to surgery and 12 months post-op
Overall Health / EuroQol VAS
大体时间:From enrollment to 12 months post-operative
The EuroQol Visual Analog Scale (EQ VAS) records the participant's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement. EQ VAS range is 0-100 where 0 represents worst health the participant can imagine and 100 best health imaginable
From enrollment to 12 months post-operative
Contacts to healthcare provider
大体时间:From enrollment and surgery to 12months after surgery
How many times a participant needs to contact a healthcare provider
From enrollment and surgery to 12months after surgery
Satisfaction to treatment and post-op rehabilitation
大体时间:From enrollment to 12 months post-op
Satisfaction to post-op rehabilitation, asked by questionnaire by multiple YES/NO questions about the surgery and recovery period. The questions include "I am satisfied to the outcome of the operation", "I would still undergo the operation if I was able to decide now", "The operation helped to my radiculopathy", "I am happy for the rehabilitation I received after the surgery", "The physiotherapy and rehabilitation advice has been sufficient after the surgery", ...
From enrollment to 12 months post-op
Function after operation
大体时间:From enrollment to 12 months post-operative
Oswestry Disability Index (ODI)
From enrollment to 12 months post-operative
6-minute walking test
大体时间:From enrollment and surgery to 12months after post-op
On elderly people's research arm, investigators assess participants' physical fitness with 6-minute walking test. Investigators observes and takes time when patient walks 6 minutes in a controlled setting and the total distance covered is measured (meters).
From enrollment and surgery to 12months after post-op
Timed up and go test (3 meters distance)
大体时间:From enrollment and surgery to 12months after post-op

A 3-meter distance is marked on the floor, with sufficient free space at the end to allow the person to turn around with an assistive device (e.g. a rollator). The front legs of the chair are positioned immediately behind the starting line. The test is performed while wearing shoes.

The person being tested sits in the chair with their back against the backrest and their arms resting on the armrests. If necessary, a mobility aid may be kept within reach and ready for use. When the tester gives the starting command ("Ready - go"), the person stands up, walks at a comfortable and safe pace beyond the line marking the 3-meter distance, ensuring that both feet cross the line, turns around, walks back, and sits down in the chair.

The time is measured to the nearest 0.01 seconds. The tester starts the timer with the command "Go." The timer is stopped when the person being tested has sat back down in the chair, with their buttocks touching the seat.

From enrollment and surgery to 12months after post-op
Walking speed
大体时间:From enrollment and surgery to 12 months postoperatively
Tested on elderly participants' arm. A 4-meter starting line and finish line are marked on the floor with tape. The test begins from a standing position behind the starting line and ends when the participant's body crosses the finish line. After the command "Go," the participant walks the marked distance twice at their usual pace, and the third time the participant walks the distance more as quickly as possible. The walking time is measured for all three trials to the nearest 0.01 seconds. The tester starts the timer with the command "Go." The timer is stopped when the participant's body crosses the finish line. From these the average is calclulated (m/s)
From enrollment and surgery to 12 months postoperatively
Grip strength
大体时间:From enrollment and surgery through 12 months postoperatively

On elderly participants' arm, maximum grip strength is measured using a hand dynamometer. During the test, the participant grips the dynamometer handle firmly, gradually increasing the force throughout the trial until maximum grip strength is reached. Each grip is maintained for 3-5 seconds. The position of the shoulder, elbow, and wrist joints must remain unchanged throughout the trial.

The measurement unit is kilograms (kg), as indicated on the outermost scale of the dynamometer display. After the grip is released, the needle remains at the maximum value reached during the trial. Before each subsequent grip, the display is reset to zero using the screw located in the center of the display.

From enrollment and surgery through 12 months postoperatively
Balance
大体时间:From enrollment and surgery through 12 months postoperatively

Measured on elderly participants' arm: Balance is assessed in three different positions: feet together, in a semi-tandem stance, and in a tandem stance. The participant may use a nearby table for support while positioning their feet into the required test position. Once the position has been achieved, the participant is instructed to release their hands from the support, after which the tester starts the timer.

The time is measured to the nearest 0.01 seconds. The tester starts the timer with the command "Go." The timer is stopped after 10 seconds have elapsed or if the participant's feet move out of the required test position or if they use their hands for support.

From enrollment and surgery through 12 months postoperatively

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 研究主任:Janne Pesonen, MD, PhD、Kuopio University Hospital; Department of Rehabilitation

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年11月1日

初级完成 (估计的)

2029年12月1日

研究完成 (估计的)

2029年12月1日

研究注册日期

首次提交

2026年3月5日

首先提交符合 QC 标准的

2026年8月27日

首次发布 (实际的)

2026年8月31日

研究记录更新

最后更新发布 (实际的)

2026年8月31日

上次提交的符合 QC 标准的更新

2026年8月27日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • KUH5960456

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

European Union Data Protection Regulations are very strict. Also, ethical committee prevents the data sharing unless absolutely necessary, and on which occasion the data request must be independently assessed

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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