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

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

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

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Other: Chiropractic Care; Other: Physical therapy intervention; Other: Sham intervention

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Federal
    • Islamabad, Federal, Pakistan, 46000
      • National Institute of rehabilitation medicine.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Independence Measure (FIM)	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.	Baseline
Functional Independence Measure (FIM)	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.	4 weeks
ASIA scale	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.	Baseline
ASIA scale	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.	4 weeks
Spine Dysfunction, Stress & Sensory-Motor Integration Questionnaire (SSSMQ)	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.	Baseline
Spine Dysfunction, Stress & Sensory-Motor Integration Questionnaire (SSSMQ)	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.	4 weeks
36-Item Short Form Survey (SF-36)	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.	Baseline
36-Item Short Form Survey (SF-36)	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.	4 weeks

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Imran Amjad, Phd, Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2022
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: March 30, 2022
• First Submitted That Met QC Criteria: April 6, 2022
• First Posted (Actual): April 7, 2022

Study Record Updates

• Last Update Posted (Actual): October 26, 2024
• Last Update Submitted That Met QC Criteria: October 23, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: REC/01287 Imran Amjad

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No