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

NCT05315115 | Completed

• 1 other identifier: REC/01287 Imran Amjad
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

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.

Other: Chiropractic Care; Other: Physical therapy intervention

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.

Other: Sham intervention; Other: Physical therapy intervention

Interventions

Sham intervention OTHER

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.

Control group

Chiropractic Care OTHER

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.

Experimental group

Physical therapy intervention OTHER

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.

Control group; Experimental group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

National Institute of rehabilitation medicine.

Islamabad, Federal, 46000, Pakistan

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• IMRAN AMJAD, PhD

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Research

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 7, 2022
• Study Start: April 7, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)