Feasibility of Home-Based Rehabilitation on Body Composition, Some Anthropometric Measures and Muscular Strength After Interruption 4-5 Years of Spinal Cord Injury: Serial Cases Study on ISIS War Survivors in Iraq

NCT06230627 | Completed DMC

• 1 other identifier: University of Mosul
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Feasibility of Home-Based Rehabilitation on Body Composition, some Anthropometric Measures and Muscular Strength after interruption 4-5 years of Spinal Cord Injury: Serial Cases Study on ISIS War Survivors in Iraq Summary Background: The war in Mosul wrecked hospitals and rehab centers, leaving a gap in rehabilitation services. This resulted in a need for alternative solutions for rehabilitation. Objectives: This study aims to create a home-based rehabilitation program (HBRP) that fits the participants\' surroundings, and also detect and evaluate how effective it is in improving body composition, some anthropometric measurements, and muscle strength after a (4-5) year break in rehabilitation. Methods: This voluntary controlled trial included 18 volunteers split into three groups: 13 people with Spinal Cord Injury (SCI) their injuries time since (53.4-55) months. They joined voluntarily into Two groups, Eight in the experimental group (Exp.) and Five in the first control (1st Con.); while Five were healthy individuals in the second control (2nd Con.); all around (21.2) years old on average. The HBRP focused on muscles and whole-body joints by using the basic equipment and exercises right at the patient\'s homes. The program consisted of five weekly sessions with a gradually increasing achievement time of (45-120) minutes per session, participants were given rest time between exercises based on their level and severity of injury. The assessment was every three months.

Conditions

Spinal Cord Injuries; Rehabilitation; Exercises

Keywords

Spinal Cord Injury, Anthropometric, Muscles Strength, Tele-rehabilitation

Outcome Measures

Primary Outcomes (4)

• Weight

  It used weight by using the electronic scale if the patient can stand up or can not hold him/her by another person and calculate the weight by subtracting the person's weight from the sum of the weight of both. The unit measure was Kilogram (kg)

  The period of trial was 6-month. At the beginning before starting the author conducted the pre-tests and after finished 3-month repeated all tests as a post1-test, and at the end of 6-month from the HBRP the author repeated all tests as a post2-test

• Anthropometric Measures (Waist/Abdomen, Pelvis, Both Thigh, Both Legs Circumferences)

  Ii used the tap measure to determine the circumferences of the Abdomen,/waist, Pelvis, Right and Left Thigh, and Right and Left Leg as anthropometric measures. The unit measure was centimeter (cm).

  The period of trial was 6-month. At the beginning before starting the author conducted the pre-tests and after finished 3-month repeated all tests as a post1-test, and at the end of 6-month from the HBRP the author repeated all tests as a post2-test

• The muscle strength of the lower limbs, head and Trunk

  The physical tests were conducted using a handheld muscle tester called MicroFET2 to evaluate the strength of participants' lower extremities, head, and trunk by using unit measure kilogram (kg) from positions (lying-down, supine, on the ground and in the bed)

  The period of trial was 6-month. At the beginning before starting the author conducted the pre-tests and after finished 3-month repeated all tests as a post1-test, and at the end of 6-month from the HBRP the author repeated all tests as a post2-test

• Body mass index (BMI)

  It used the criteria of BMI according to WHO

  The period of trial was 6-month. At the beginning before starting the author conducted the pre-tests and after finished 3-month repeated all tests as a post1-test, and at the end of 6-month from the HBRP the author repeated all tests as a post2-test

Study Arms (3)

Rehabilitation program

EXPERIMENTAL

The Home-Based Rehabilitation Program (HBRP) As a first procedure, detailed interviews were conducted with each participant at the beginning of the study to gather information about their physical, psychological, and social well-being. This information helped the authors create personalized rehabilitation plans for each participant to ensure their participation in the study for the entire 6 months period. Through our study objectives, the authors used body composition such as height, weight, BMI and some anthropometric measurements for body parts circumferences by using tape measurements. Also, muscle strength tests were performed on participants\' lower and upper extremities, head, and trunk to measure various movements. The 2nd control group completed their measurements and tests at college. Additionally, a clinical test using the American Spinal Injury Association scale (ASIA) was conducted on each participant to assess sensory feeling.

Other: Home-Based Rehabilitation rogram

First Control Group Five People with SCI

NO INTERVENTION

This group only conducted the pre-post1 and post2-tests

Healthy Group Five people

NO INTERVENTION

This group only conducted the pre-post1 and post2-tests

Interventions

Home-Based Rehabilitation rogram OTHER

The intervention is distinguished from others in that it applies to patients' homes and the trial was followed up in the middle of complex conditions of the COVID-19 Pandemic. Also, the challenge was represented by the HBRP applied to patients with SCIs after 4-5 years of rehabilitation interruption.

Also known as: HBRP

Rehabilitation program

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• A spinal cord injury resulting in traumatic injury.
• The participant should have paraplegia and he/she able to use his/her upper limbs to do exercises program

You may not qualify if:

• Any person has no traumatic spinal cord injury or his/her injury resulted by such as caused diseases as well as he/she has a tetraplegia

Sponsors & Collaborators

• University of Mosul: lead

Study Sites (1)

University of Sfax

Sfax, 00216, Tunisia

Location

Related Publications (10)

• Duran FS, Lugo L, Ramirez L, Eusse E. Effects of an exercise program on the rehabilitation of patients with spinal cord injury. Arch Phys Med Rehabil. 2001 Oct;82(10):1349-54. doi: 10.1053/apmr.2001.26066.

  PMID: 11588736 BACKGROUND

• Abilmona SM, Sumrell RM, Gill RS, Adler RA, Gorgey AS. Serum testosterone levels may influence body composition and cardiometabolic health in men with spinal cord injury. Spinal Cord. 2019 Mar;57(3):229-239. doi: 10.1038/s41393-018-0207-7. Epub 2018 Oct 22.

  PMID: 30349112 BACKGROUND

• Khorasanizadeh M, Yousefifard M, Eskian M, Lu Y, Chalangari M, Harrop JS, Jazayeri SB, Seyedpour S, Khodaei B, Hosseini M, Rahimi-Movaghar V. Neurological recovery following traumatic spinal cord injury: a systematic review and meta-analysis. J Neurosurg Spine. 2019 Feb 15;30(5):683-699. doi: 10.3171/2018.10.SPINE18802. Print 2019 May 1.

  PMID: 30771786 BACKGROUND

• Modlesky CM, Bickel CS, Slade JM, Meyer RA, Cureton KJ, Dudley GA. Assessment of skeletal muscle mass in men with spinal cord injury using dual-energy X-ray absorptiometry and magnetic resonance imaging. J Appl Physiol (1985). 2004 Feb;96(2):561-5. doi: 10.1152/japplphysiol.00207.2003. Epub 2003 Oct 3.

  PMID: 14527962 RESULT

• Gorgey AS, Dolbow DR, Dolbow JD, Khalil RK, Gater DR. The effects of electrical stimulation on body composition and metabolic profile after spinal cord injury--Part II. J Spinal Cord Med. 2015 Jan;38(1):23-37. doi: 10.1179/2045772314Y.0000000244. Epub 2014 Jul 8.

  PMID: 25001669 RESULT

• Yuen J, Thiyagarajan CA, Belci M. Patient experience survey in telemedicine for spinal cord injury patients. Spinal Cord. 2015 Apr;53(4):320-3. doi: 10.1038/sc.2014.247. Epub 2015 Jan 27.

  PMID: 25622730 RESULT

• Richard-Denis A, Dionne A, Mputu PM, Mac-Thiong JM. Do all patients with functional motor-incomplete (AIS-D) traumatic spinal cord injury need specialized inpatient functional rehabilitation? A prospective observational cohort study proposing clinical criteria for home-based rehabilitation after acute care. J Spinal Cord Med. Published online 2023. doi:10.1080/10790268.2023.2200354 25. Hicks AL, Martin KA, Ditor DS, et al. Long-term exercise training in persons with spinal cord injury: Effects on strength, arm ergometry performance and psychological well-being. Spinal Cord. 2003;41(1):34-43. doi:10.1038/sj.sc.3101389

  RESULT

• Hicks AL, Martin KA, Ditor DS, Latimer AE, Craven C, Bugaresti J, McCartney N. Long-term exercise training in persons with spinal cord injury: effects on strength, arm ergometry performance and psychological well-being. Spinal Cord. 2003 Jan;41(1):34-43. doi: 10.1038/sj.sc.3101389.

  PMID: 12494319 RESULT

• Richard-Denis A, Dionne A, Mputu PM, Mac-Thiong JM. Do all patients with functional motor-incomplete (AIS-D) traumatic spinal cord injury need specialized inpatient functional rehabilitation? A prospective observational cohort study proposing clinical criteria for home-based rehabilitation after acute care. J Spinal Cord Med. 2024 Sep;47(5):753-764. doi: 10.1080/10790268.2023.2200354. Epub 2023 Apr 21.

  PMID: 37083554 RESULT

• Ji X, Xu Z, Liu D, Chen Y. Effects of exercise training on neurological recovery, TGF-beta1, HIF-1alpha, and Nogo-NgR signaling pathways after spinal cord injury in rats. Clinics (Sao Paulo). 2023 Jul 27;78:100236. doi: 10.1016/j.clinsp.2023.100236. eCollection 2023.

  PMID: 37515927 RESULT

Related Links

• This scientific association aims to develop the members and participant in rehabilitation
• The CSRO is dedicated to the funding of targeted research to maximize functional recovery and cure paralysis caused by spinal cord injury. We envision a world without paralysis caused by spinal cord injury.

MeSH Terms

Conditions

Spinal Cord Injuries; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: There were two control groups in this study, the first were people with SCI who only conducted the pre-post1 and post2-tests, additionally, the second group were healthy people also they just conducted the pre-post1 and post2-tests. The authors used these groups to control the changes which may happen with time which could affect the results
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eternal Intervention (Home-Based Rehabilitation Program) Three groups : Experimental group with SCI + Control group 1 with SCI + Control group 2 Healthy people

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: January 30, 2024
• Study Start: December 21, 2021
• Primary Completion: August 25, 2022
• Study Completion: March 15, 2023
• Last Updated: April 22, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After the study published online for 10 months
• Access Criteria: Any author needs the data or information about the study methods, he/she will be able to get it by contact with following this email and phone: m.a.fathi@uomosul.edu.iq 009647701680770

Locations

TU (1)