跳至主要内容
临床试验/NCT05315115
NCT05315115已完成不适用

To Investigate the Effects of Four Weeks of Intensive Chiropractic Care When Added to Usual Care for Adults With Spinal Cord Injuries.

Riphah International University1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2022年4月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
1
主要终点
36-Item Short Form Survey (SF-36)

研究概览

简要总结

To determine the effects of chiropractic care on spasticity, functional outcomes and quality of life in Spinal Cord Injuries in adults.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults with both genders (Male and Female).
  • •Age above 20 years.
  • •Spinal Cord Injuries adults.

排除标准

  • •Spinal Cord Injury due to Traumatic Brain Injury.
  • •Patients having cognitive impairments.
  • •Patients having associated Neurological Pathologies.
  • •Patients who are unable to follow the treatment plan.

研究组 & 干预措施

Experimental group

Experimental

A registered chiropractor will assess the entire spine, and both sacroiliac joints will be assessed for vertebral subluxation by a registered chiropractor. The clinical indicators that will be used to assess the function of the spine before spinal adjustment intervention include assessing for joint tenderness to palpation manually palpating for a restricted intersegmental range of motion, assessing for palpable asymmetric intervertebral muscle tension, and any abnormal or blocked joint play and end-feel of the joints.

干预措施: Chiropractic Care (Other)

Experimental group

Experimental

A registered chiropractor will assess the entire spine, and both sacroiliac joints will be assessed for vertebral subluxation by a registered chiropractor. The clinical indicators that will be used to assess the function of the spine before spinal adjustment intervention include assessing for joint tenderness to palpation manually palpating for a restricted intersegmental range of motion, assessing for palpable asymmetric intervertebral muscle tension, and any abnormal or blocked joint play and end-feel of the joints.

干预措施: Physical therapy intervention (Other)

Control group

Sham Comparator

The participant's head and/or spine will be moved in ways that include passive and active movements, similar to what is done when assessing the spine by a chiropractor.No spinal adjustment will be performed during any control intervention.

干预措施: Physical therapy intervention (Other)

Control group

Sham Comparator

The participant's head and/or spine will be moved in ways that include passive and active movements, similar to what is done when assessing the spine by a chiropractor.No spinal adjustment will be performed during any control intervention.

干预措施: Sham intervention (Other)

结局指标

主要结局

36-Item Short Form Survey (SF-36)

时间窗: 4 weeks

The SF-36 was originally designed as a generic health measure but has also been applied to specific disease populations. It comprises 36 questions that cover eight domains of health. Scores for the different domains are converted and pooled using a scoring key, for a total score indicating a range of low to the high quality of life. This tool will be measured after 4 weeks.

ASIA scale

时间窗: 4 weeks

The American Spinal Injury Association (ASIA) impairment scale describes a person's functional impairment as a result of a Spinal Cord Injury. This scale indicates how much sensation a person feels after light touch and a pinprick at multiple points on the body and tests key motions on both sides of the body. This tool will be measured after 4 weeks.

Spine Dysfunction, Stress & Sensory-Motor Integration Questionnaire (SSSMQ)

时间窗: 4 weeks

The SSSMQ is a newly developed tool to assess Spine Dysfunction Characteristics, logical and Psychological Stress Symptoms, and Multimodal and Sensorimotor Integration Dysfunction Symptoms. A baseline assessment of a participant will be done before the start of the intervention. This tool will be measured after 4 weeks.

Functional Independence Measure (FIM)

时间窗: 4 weeks

The Functional Independence Measure (FIM) is an instrument that was developed as a measure of disability for a variety of populations and is not specific to any diagnosis. FIM is comprised of 18 items, grouped into 2 subscales - motor and cognition. Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item. This tool will be measured after 4 weeks.

Functional Independence Measure (FIM)

时间窗: Baseline

The Functional Independence Measure (FIM) is an instrument that was developed as a measure of disability for a variety of populations and is not specific to any diagnosis. FIM is comprised of 18 items, grouped into 2 subscales - motor and cognition. Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item. This tool will be measured at baseline.

ASIA scale

时间窗: Baseline

The American Spinal Injury Association (ASIA) impairment scale describes a person's functional impairment as a result of a Spinal Cord Injury. This scale indicates how much sensation a person feels after light touch and a pinprick at multiple points on the body and tests key motions on both sides of the body. This tool will be measured at baseline.

Spine Dysfunction, Stress & Sensory-Motor Integration Questionnaire (SSSMQ)

时间窗: Baseline

The SSSMQ is a newly developed tool to assess Spine Dysfunction Characteristics, logical and Psychological Stress Symptoms, and Multimodal and Sensorimotor Integration Dysfunction Symptoms. A baseline assessment of a participant will be done before the start of the intervention.

36-Item Short Form Survey (SF-36)

时间窗: Baseline

The SF-36 was originally designed as a generic health measure but has also been applied to specific disease populations. It comprises 36 questions that cover eight domains of health. Scores for the different domains are converted and pooled using a scoring key, for a total score indicating a range of low to the high quality of life. A baseline assessment of a participant will be done before the start of the intervention.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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