跳至主要内容
临床试验/CTRI/2024/10/076034
CTRI/2024/10/076034尚未招募不适用

A Spine Exerciser Device

School of Physiotherapy1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年11月14日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Spinal joint Range of motion.

研究概览

简要总结

TITLE : Development and Validation of a Spine Exerciser Device to Enhance Spinal Flexibility and Muscular Strength.

INVESTIGATOR : Dr Krupali Gajera ,School of Physiotherapy,RK University, Dr. Priyanshu Rathod, Professor,School of Physiotherapy.RK University.

Aim:The primary aim of this project is to design and develop a Spine Exerciser Device that provides a comprehensive solution for enhancing spinal health by targeting spinal muscles through strengthening and stretching exercises.

Objectives:

-Design and develop a user-friendly Spine Exerciser Device that strengthens and stretches spinal muscles, improving flexibility and reducing injury risk, while ensuring accessibility for individuals of all fitness levels.

  • Conduct thorough testing and evaluation to guarantee safety, effectiveness, and user satisfaction, and provide clear instructions and guidelines for proper use and maintenance.

  • Explore partnerships with public fitness facilities to integrate the device into their equipment offerings, ensuring seamless adoption and promoting comprehensive spinal conditioning for a broader audience.

Material

 Device Components:

-  High-quality steel frame for durability.

-  Ergonomic foam padding for user comfort.

-  Adjustable bars with non-slip grips.

-  High-tension springs for resistance.

-  Safety locks to secure the device during use.

Phase 1: Need Analysis for developing A SPINE EXERCISER DEVICE by clinical rationale. systematic review and focus group discussion.

Literature Review and Systematic Review: A comprehensive literature review reveals that while numerous studies from search engines like PubMed and Google patent assess the effectiveness of various spine exercisers in clinical and community settings, gaps exist in addressing the simultaneous requirements for both strengthening and stretching spinal muscles with existing devices.

Focus Group Discussions: Discuss preferences and expectations regarding features, usability, safety considerations, and accessibility of the Spine Exerciser Device in public fitness facilities.

Clinical Rationale Development: Based on literature findings and focus group insights, a Spine Exerciser Device is justified to meet the critical need for simultaneously strengthening and stretching spinal muscles, thereby potentially reducing injury risks, enhancing posture, and improving overall spinal health, complementing traditional exercise routines and filling gaps in existing public fitness equipment.

Phase 2: Prototype Device Development

Design**:**

Collaborate with engineers and designers to translate refined concepts into detailed engineering drawings and specifications. Determine materials, components, and manufacturing processes suitable for producing prototypes of the Spine Exerciser Device.

Phase 3: Efficacy Testing

Study Design**:**

Determine study parameters such as sample size, participant demographics (e.g., consent, age, fitness level), and duration of the study.

Consider ethical considerations and obtain necessary approvals from relevant institutional review boards (IRBs) or ethics committees.

Sampling Technique:

Convenience sampling for initial prototype testing.

Stratified random sampling for public testing to ensure diverse participant representation.

 Outcome measures:

Spinal joint Range of Motion with Goniometer and Spinal Strength with the  increased number of Curl-ups.

Selection Criteria:

Inclusion Criteria:

  • Adults aged 18-65 years.

  • No current spinal injuries or severe musculoskeletal disorders.

  • Able to provide informed consent.

Exclusion Criteria:

  • History of spinal surgery in last one year.

  • Pregnancy.

  • Any condition that would contraindicate physical exercise.

Procedure:

-  Participants will use the device and perform both trunk flexion and extension by curl-ups and spinal stretches.

-  Each session will last 5 minutes and immediate effect will be measured by taking range of motion and number of repetition of curl ups for the spinal strength.

 - Pre- and post-intervention assessments will measure spinal muscle strength, flexibility, and user satisfaction immediately after performing exercises on device.

Data will be analyzed to assess improvements in spinal health and overall effectiveness of the device.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Healthy individuals, No Current Spinal Injuries or Severe musculoskeletal Disorders.
  • Able to provide informed Consent.

排除标准

  • Patient with history of spinal injury in last one year, pregnant women Conditions that can contraindicate Physical exercise.

结局指标

主要结局

Spinal joint Range of motion.

时间窗: Two time points : Before and after the perfromaing exercsies

次要结局

  • Strength of Spinal muscles :Rectus Abdominis,Transverse Abdominis.(Pre and post to perfromaing exercsies on Spinal Exercseiring devcie)
  • Safety and feasibility of Device.(Two time points :)

研究者

发起方
School of Physiotherapy
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dr Krupali Gajera

School of Physiotherapy,RK University

研究点 (1)

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