Effects of Intensive Chiropractic Care to Usual Care for Adults With Spinal Cord Injuries.

Sponsor
Riphah International University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05315115
Collaborator
(none)
40
1
2
6.8
5.9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Sham intervention
  • Other: Chiropractic Care
  • Other: Physical therapy intervention
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
ResearchResearch
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
To Investigate the Effects of Two Weeks of Intensive Chiropractic Care When Added to Usual Care for Adults With Spinal Cord Injuries.
Actual Study Start Date :
Apr 7, 2022
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental group

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.

Other: Chiropractic Care
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.

Other: Physical therapy intervention
The standardized treatment protocol will be provided according to the guidelines, which will include various modalities and treatment approaches, including stretching exercises; massage; strengthening exercises of weak muscles, weight-bearing, balance (static and dynamic) and gait training; electrical stimulation; treadmill use; and endurance training for the improvement of gait, motor function, strength and functional mobility in Spinal Cord Injuries children, where Conventional Therapy will be provided according to the respective needs of the individual patient.

Sham Comparator: Control group

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.

Other: Sham intervention
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. The sham intervention will also include the participants moving into adjustment setup positions similar to how the chiropractor would typically set up a patient with no joint pre-loading or adjustive thrust.

Other: Physical therapy intervention
The standardized treatment protocol will be provided according to the guidelines, which will include various modalities and treatment approaches, including stretching exercises; massage; strengthening exercises of weak muscles, weight-bearing, balance (static and dynamic) and gait training; electrical stimulation; treadmill use; and endurance training for the improvement of gait, motor function, strength and functional mobility in Spinal Cord Injuries children, where Conventional Therapy will be provided according to the respective needs of the individual patient.

Outcome Measures

Primary Outcome Measures

  1. Functional Independence Measure (FIM) [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.

  2. Functional Independence Measure (FIM) [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.

  3. ASIA scale [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.

  4. ASIA scale [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.

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

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

  7. 36-Item Short Form Survey (SF-36) [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.

  8. 36-Item Short Form Survey (SF-36) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Adults with both genders (Male and Female).

  • Age above 20 years.

  • Spinal Cord Injuries adults.

Exclusion criteria

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Institute of rehabilitation medicine. Islamabad None Selected Pakistan 46000

Sponsors and Collaborators

  • Riphah International University

Investigators

  • Principal Investigator: IMRAN AMJAD, PhD, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Riphah International University
ClinicalTrials.gov Identifier:
NCT05315115
Other Study ID Numbers:
  • REC/01287 Imran Amjad
First Posted:
Apr 7, 2022
Last Update Posted:
Apr 26, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 26, 2022