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Spinal Cord InjuriesHBRP-SCINCT06230627

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

A study testing Home-Based Rehabilitation rogram in people with Spinal Cord Injuries and Rehabilitation, run by University of Mosul at 1 site in Tunisia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Spinal Cord Injuries, Rehabilitation, Exercises
What is being tested?
Home-Based Rehabilitation rogram
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteTunisia
Study dates
21 Dec 2021to 15 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Tunisia1 site
  • University of Sfax

    Sfax, 00216

Other trials in Tunisia

About this study

Official title: University of Mosul, College of Physical Education and Sport Sciences & University of Sfax, High Institute of Sport and Physical Education at Sfax

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.

Read the detailed description

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 participant; 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.

Innovatively, this study stands out by introducing an HBRP tailored for individuals with SCI after interruption sustained (4 - 5) years ago. This unique approach not only addresses the challenges posed by the interruption of previous rehabilitation efforts but also seeks to uncover the efficacy of rehabilitation in these specific circumstances.

Detailed Description:

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

Background:

Spinal Cord Injury (SCI) is a complex pathology that requires skills in assessment, treatment, and rehabilitation, SCI is a large topic area. Approximately (90%) of SCI cases occur as a result of traumatic causes Globally, incidence varies from 40 to 80 cases per million population. So, people with injuries consequences are becoming more frequent due to conflicts and wars. In Iraq, the main reasons for the occurrence of this injury due to were the Islamic State in Iraq and Syria (ISIS) war, which is resulting in enormous unmet rehabilitation needs. Alarcon Cieza found in his study Rehabilitation the health strategy of the 21st Century that the rehabilitation stakeholders need to bring together the distinct portraits of rehabilitation under the concept of functioning because much of these unmet needs are concentrated amongst the poorest populations in low- and middle-income countries and conflict-affected settings, which are often ill-equipped to cope with these increasing needs for rehabilitation services. Iraq is regarded as one of these countries its health sectors, including rehabilitation, have been exhausted due to wars and armed violence. However, rehabilitation can be effective across almost all conditions, therefore in some ways, we should have been so backwards about recognizing the effectiveness of rehabilitation for many years.

It is worth noting that healthcare problems are among the most complex problems faced by human beings, especially under conditions of war, armed conflicts, terrorist operations and post-war secretions. In low-middle income countries, so many people would die from SCI within a year, two years, or three years from infection, renal failure, and so on, and also people could not work, and they either were at home or in residential care, just waiting to die. One of the defining characteristics of rehabilitation is that there are many interventions; in contrast to most medical conditions, rehabilitation can take place in any setting as a process for problem-solving.

In Iraq, war-related destruction of health institutions and rehabilitation centers has led to a focus on home-based rehabilitation programs (HBRP) and new sporting activities as positive and alternative approaches for rehabilitating individuals with SCI. This article emphasizes the significance of home-based rehabilitation for individuals with SCI to prevent complications that arise from neglecting rehabilitation. Neglecting rehabilitation can result in complex health problems, a major concern observed among the study participants who discontinued rehabilitation due to ineffective and insufficient programs. Additionally, there was a notable mismatch between the participantscircumstances and the available rehabilitation systems and methods. To ensure continuous and successful rehabilitation for individuals with SCI, it is important to implement exercise regimes that intrinsically motivate them. Robert et al, confirmed that rehabilitation can occur at home, and it is a practical matter of what is the best way to organize it so that the patient is safe, the necessary equipment is available, and the therapists and other team members, time is used appropriately. The process is a standard problem-solving process individualized to the patient, which is necessary when solving any problem. Reconsidering rehabilitation at home by introducing new sporting activities has been recognized as a positive and desirable area of rehabilitation 8.

Objectives: Innovatively, this study stands out by introducing an HBRP tailored for individuals with SCI after interruption sustained between (4 - 5) years ago. This unique approach not only addresses the challenges posed by the interruption of previous rehabilitation efforts but also seeks to uncover the efficacy of rehabilitation in these specific circumstances.

The main contributions of this study are:

To the best of the authors' knowledge, this is the first study in Iraq that highlighted the surviving victims of ISIS with SCIs.

The preparation of a home-based rehabilitation program (HBRP) that lasted for six months and that was compatible with the participants' living and environmental conditions as an alternative solution for conditions after the war also, at the time of the COVID-19 pandemic when everything was under the closure.

Assessing the effectiveness of rehabilitation on some anthropometric and physical variables in participants with SCI following participants' stopping of rehabilitation for (4-5) years after SCI.

The study raises two questions Does the home-based rehabilitation program (HBRP) affect people with spinal cord injury through interruption of rehabilitation for 4-5 years? Is the HBRP effects on variables such as body composition (Weight, BMI); Anthropometric Measures, and Muscle strength? 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. 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, similar to a previous study by Akita et al.. 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 and voluntary movement potential on both sides of the body.

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) 11. The Exp. group underwent a 6-month intensive rehabilitation program that involved whole-body exercises, including stretching, strength, endurance, and aerobic training, which was prepared based on previous studies 12. The program included five weekly sessions of (45-120) minutes, gradually increasing in intensity. It encompassed various exercises like bed exercises, rubber ball exercises for strength and balance, trunk flexibility exercises, crawling, rolling, ball-related movements, and exercises on parallel bars. Also, aerobic exercises targeted cardiorespiratory fitness. While weight exercises focused on the upper limbs, shoulders, chest, and back. Rest periods were personalized based on injury severity and overall health. The authors updated the exercises based on regular assessments every 3 months, tracking muscle strength and endurance. The authors created a contact link for coordination among medical, rehabilitative teams, and participants, families, overcoming some challenges within the Iraqi healthcare system.

To address complex complications like bed sores, renal infections, and muscle atrophy, the authors followed the method of psychological support. This method aimed to stimulate patients, willpower, encouraging them to overcome complications and emphasizing the benefits of rehabilitation for improved overall health and independence, by made WhatsApp group was created to facilitate information sharing and provide visual evidence of successful cases, inspiring and encouraging participants. Furthermore, the participant weight and BMI were monitored due to the potential impact of factors such as limited movement and hormonal changes on weight fluctuations, as recommended in previous studies.

The study highlights the participants the participants fidelity to treatment, as evidenced by positive outcomes and sustained progress beyond the conclusion of the therapeutic experiment. The participants demonstrated loyalty through ongoing communication with the main author, seeking feedback on their rehabilitation stages who reach it. Notably, some participants achieved the significant milestone of walking by standard walker with the assistive device Knee Ankle Foot Orthosis(KAFO).

The study used Two-way ANOVA repeated measures as a statistical analysis method, with effect size and improvement percentage (IP) as measures, and (IBM-SPSS statistics processor version 20) for data analysis. A statistical significance level of P≤ 0.05 (alpha) was used.

Being tested
Home-Based Rehabilitation rogram
Keywords
Spinal Cord Injury, Anthropometric, Muscles Strength, Tele-rehabilitation
Medical subject headings
Spinal Cord Injuries, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Home-Based Rehabilitation rogramOther

    Also called HBRP

    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.

Study groups in NCT06230627
Study groupRoleWhat they receive
Rehabilitation programExperimentalThe 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.
Receives: Other: Home-Based Rehabilitation rogram
First Control Group Five People with SCINo interventionThis group only conducted the pre-post1 and post2-tests
Healthy Group Five peopleNo interventionThis group only conducted the pre-post1 and post2-tests

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 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

  2. 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).

    Measured: 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

  3. 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)

    Measured: 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

  4. Body mass index (BMI)

    It used the criteria of BMI according to WHO

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2024
  2. Study start21 Dec 2021
  3. Primary completion25 Aug 2022
  4. Study completion15 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Eternal Intervention (Home-Based Rehabilitation Program) Three groups : Experimental group with SCI + Control group 1 with SCI + Control group 2 Healthy people
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06230627
Sponsor's protocol ID
University of Mosul
Acronym
HBRP-SCI
Status last verified
Mar 2025
First submitted
19 Jan 2024
Last updated
22 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The authors agree to share the data of study after the study will be published online and after a request by email

Publications

  • 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.

    PubMed 11588736
  • 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.

    PubMed 30349112
  • 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.

    PubMed 30771786
  • 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.

    PubMed 14527962
  • 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.

    PubMed 25001669
  • 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.

    PubMed 25622730
  • 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

  • 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.

    PubMed 12494319
  • 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.

    PubMed 37083554
  • 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.

    PubMed 37515927

Questions about this trial

What is this clinical trial studying?

A study testing Home-Based Rehabilitation rogram in people with Spinal Cord Injuries and Rehabilitation, run by University of Mosul at 1 site in Tunisia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight (time frame: 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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06230627, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.

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