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 — HBRP-SCI  

Spinal Cord Injury Clinical Trial

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

Status Completed

Clinical 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 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. Results: The study found that HBRP were not significant differences in weight, BMI, some anthropometric measures and some muscle strength tests However, the HBRP had significant effects on waist/abdomen, pelvis, and left thigh anthropometric variables, with a large effect sizes and ranged between (η2= 0.84 - 0.95); and improvement percentages ranging from (IP= 2.4-16.2%), also had a large effect size on all lower extremity tests, head, and trunk, also improvement percentages were ranging (29.6-242.8%), exclude the pelvis elevating test. Also, there was a significant difference between the Exp. and 1st Con group in the Eight muscles test (P= <0.05) for the favour Exp. group. 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. Conclusions: The study concluded that HBRP affected positively the muscles morphologically and functionally despite a stop in rehabilitation for a long period of (4-5) years for individuals with SCI.

Clinical Trial 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. Results: The study found that HBRP were not significant differences in weight, BMI, some anthropometric measures and some muscle strength tests However, the HBRP had significant effects on waist/abdomen, pelvis, and left thigh anthropometric variables, with a large effect sizes and ranged between (η2= 0.84 - 0.95); and improvement percentages ranging from (IP= 2.4-16.2%), also had a large effect size on all lower extremity tests, head, and trunk, also improvement percentages were ranging (29.6-242.8%), exclude the pelvis elevating test. Also, there was a significant difference between the Exp. and 1st Con group in the Eight muscles test (P=0.05) for the favor Exp. group. 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. Conclusions: The study concluded that HBRP affected positively the muscles morphologically and functionally despite a stop in rehabilitation for a long period of (4-5) years for individuals with SCI. 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. Results the means and standard deviations which represented the baseline score for each variable, and the results of the variances between study groups for body composition and some anthropometric measures regarding the effectiveness of the HBRP on weight, BMI, and anthropometric measurements, also within groups after 3-month as a primary measure, between 3-month 6-month and between primary and secondary measures. Table 2 shows no significant differences in variables weight and BMI among the study groups over 6 months. Also, the measurements of waist/abdomen, pelvis, and thigh circumference did not differ significantly between groups. While, significant differences were observed in the measures of the right leg (F= 7.56, P= .005) and the left leg (F= 8.12, P= .004). The second control group had a larger mean of the right leg (Mean= 34.80 ± 1.42) and the left leg (Mean= 34.60 ± 1.62) compared to the experimental group and the first control group. Table 3 shows the variances within groups, the effect sizes, and improvement percentages. There are large effect sizes for HBRP on all variables and the range of IPs indicates a high ratio for anthropometric variables in the Exp. group which ranged between (2.4% - and 16.2%) compared to the other groups. As well as, the range of effect sizes were (0.97 - 0.99) Additionally, the primary results show a noticeable improvement in the pelvic circumference as a result of the response to exercise, also the change was in an increase the BMI. As for the secondary measurements, our improvement appeared in the waist circumference in addition to the pelvic circumference and the left thigh circumference in favor of the post-measures. The variances between Exp. and 1st Con. Tables 4 and 5 show the means and standard deviations which represented the baseline score for each test of muscle strength and the results of the variances between study groups for muscles which work on the lower extremities under the lesion, on the head, on the trunk, and the pelvis. The mean differences indicate the increase in the scores of muscle strength with time as a result of the effectiveness of HBRP. Also, table 4 shows, there are significant differences among the Exp.; 1st Con.; and 2nd Con. groups favor the 2nd Con. group in all tests so the P-value was 0.05 except for the test head elevation from lying-down position which was reported no significant difference among study groups and (F=2.098, P= .157). From table 5, the significant differences between Exp. and 1st Con. group for favor the Exp. group in test right knee-hip flexion from lying-down position (MD= 6.06, P= .005); both knees-hips flexion (MD= 5.64, P= .001); hip extension from 45° with the ground (MD= 3.83, P= .014); right lower limb adduction from knee flexed 90°from supine (MD= 2.97, P= .011); and for left lower limb (MD= 4.30, P= .001); pelvis elevation from open legs-knees-feet based on the ground (MD= 8.97, P=.001); pelvis elevation from close legs-knees-feet based on the ground (MD= 9.85, P= .000). Also, from a supine position, the test of both knees' extension from 90° (MD= 4.35, P= .049); right knee extension from 45° (MD= 4.68, P= .022); left hip flexion (MD= 10.04, P= .000). Additionally, table 5 shows the variances within groups were significant and the difference sometimes between pre-post1 and post1-post2 tests as a primary result and in most tests of secondary results happened and for a favor the post-tests except within the test of right Knee Extension from 45° and supine position it was not significant. Also, the effect sizes were large and ranged between (η2=0.84 - 0.95); also, the IPs in muscle strength tests favored the Exp. group as compared to 1st Con. and 2nd Con. groups, the IPs ranged between (29.6% - 242.8%). Discussion The noticeable effect of HBRP was clear on variables studied through large effect sizes, and a superior improvement percentage in the Exp. group compared with other groups. However, there were no significant differences in weight, BMI, and some anthropometric measures over 6 months, possibly because of the relatively short duration of HBRP compared to the longer period without rehabilitation. Nevertheless, significant differences were found in waist/abdomen and pelvis measurements before and after the test. A study by Bakkum et al found that a 16-week hand-cycling program for people with chronic SCI reduced waist circumference, trunk and Android fat percentage. Another study found that individuals with complete injuries had higher weight in paraplegia compared to tetraplegia. However, some studies state that body mass index may not accurately describe adiposity in SCI individuals. Additionally, leg lean tissue mass decreased by (15.1%) one year after injury. Thus, the changes in body composition after injury often involve muscle atrophy and decreased fat-free mass. Differences between study groups were not significant, except for the healthy group compared to Exp. group and 1st Con. group. Lack of long-term rehabilitation in SCI individuals led to muscle atrophy and a decline in physical shape as compared to the healthy group. SCI individuals had increased body fat mass due to prolonged physical inactivity after injury. Jennifer L. Maher et al. found that exercise likely helps in maintaining or promoting a stable body weight and they concluded that paraplegia results in higher weight than tetraplegia. Longer injury duration in tetraplegia was associated with higher waist circumference and weight, yet it was not statistically significant, this result agrees with the study result. Furthermore, maintaining ideal weight and BMI is important for SCI individuals, and evidence supports the role of chronic exercise in the prevention and treatment of secondary complications associated with dyslipidemia and insulin resistance. Exercise likely assists in maintaining a stable body weight or promoting a reduction in body mass, although less experimental evidence supports the use of exercise as a monotherapy for weight loss after SCI. This has indeed happened with the participants in our study. Loss of body mass may be more effectively achieved by combining exercise with caloric restriction and dietary intake with reduced intake of saturated fats. Ishimoto et al. recommended in their study that routine monitoring of body composition is necessary, especially among those with multiple risk factors such as SCI, to identify individuals in need of preventive and therapeutic interventions. The aforementioned results show the effectiveness of HBRP through the large effect size values also, the IPs were good at the end of HBRP. So, the clarification of the interpretation of different quantities effect size, that the study encompasses several variables, and the rehabilitation protocol targets distinct muscle groups integrated with diverse neural networks, exerting varying influences on the magnitude of response observed in each participant with SCI, contingent upon the severity and the size of their nerve's damage which are not the same for participants. Consequently, the outcomes manifest disparate effect sizes, a finding that is substantiated. This clarification is confirmed by the Mahalanobis distance D is the multivariate generalization of Cohen's d, and can be used as a standardized effect size for multivariate differences between groups. An important issue in the interpretation of D is heterogeneity, that is, the extent to which contributions to the overall effect size are concentrated in a small subset of variables rather than evenly distributed across the whole set. Here I present two heterogeneity coefficients for D based on the Gini coefficient, a well-known index of inequality among values of a distribution. In addition, significant differences were observed in muscle strength tests which work under the lesion and muscles connecting the lower extremities to the lesion area. Despite partial paralysis and varying damage levels, the HBRP had a positive impact on muscle strength. The study found that HBRP was valuable for individuals with SCIs, as it improves their care. Concerning rehabilitation at home, J Yuen et al. showed that most patients found the service of telemedicine was high quality and useful to their care; this provides evidence, from SCI patients' perspective, that telemedicine service has an important role in their management. Moreover, Khorasanizadeh et al. concluded that they demonstrated how neurological recovery after TSCI is significantly dependent on injury factors (i.e., severity, level, and mechanism of injury), but is not associated with the type of treatment or country of origin where the treatment is delivered. Also, studies have shown that regular physical activity is effective in improving fitness in SCI people, although most of the evidence is based on relatively short studies focused on paraplegia or tetraplegia individuals. Richard-Denis et al. concluded in their study that Home-based rehabilitation in selected individuals sustaining an acute AIS-D TSCI is a safe and interesting strategy to optimize the long-term outcome in terms of functional recovery, physical, as well as to optimize inpatient rehabilitation resources. Hicks et al. showed that twice-weekly regular exercise training for people with SCI can improve physical. Duran et al. found that a directed exercise program positively affected mobility, strength, coordination, aerobic resistance, and relaxation. As well as Ralph et al. discovered that motor scores improved based on injury severity within a year. Moreover, Mohr et al. in their study observed a (12%) increase in muscle mass after one year of training, which partially normalized in all subjects. As well as, Ji, Xubin et al. found in their study that the mechanism of exercise training may be connected to the inhibition of the Nogo-NgR signaling pathway to promote neuronal growth as an explanation of development that occurred after rehabilitation. Also, V. L. Phillips et al. Preliminary evidence suggests that in-home telephone or video-based interventions do improve health-related outcomes for newly injured SCI patients, moreover may be cost-saving if program costs are more than offset by a reduction in rehospitalization costs, but differential advantages of video-based interventions versus telephone. The differences were significant between the Exp. group and the 1st Con. group in some tests. However, not all tests showed significant differences due to chronic complications resulting from neglecting rehabilitation for extended periods, affecting participants' responses. The differences were significant within groups for all tests of muscle strength and some anthropometric measures. The impact of the HBRP on muscle groups varies based on the injury level and severity, as noted by Kroll et al. The 2nd Con. group performed better in all tests. Participants with high spirits, strong will, and commitment to the program achieved better results. Feigin et al. emphasized that individualized management plans and clinical reasoning skills are necessary for each person unique response to treatment. Despite facing chronic complications from neglecting rehabilitation, the Exp. group showed improvement and reduced the risks of various associated complications, such as cardiorespiratory issues, anemia, and urinary tract infections. Discontinuing rehabilitation for several years resulted in physical deterioration and adverse psychological and social conditions for participants. However, individuals with spinal cord injuries face significant challenges in healthcare, especially in low-middle-income countries, as discussed by Wade. Various studies have emphasized the importance of habitual exercise for individuals with SCI, as it enhances activity, life satisfaction, and overall health, as concluded by Nash. In this study, it is crucial to recognize the constraint imposed by a relatively modest sample size, potentially limiting the applicability of the findings to broader populations. The implementation of rehabilitation on a large scale, mirroring the conditions faced by study participants, presents inherent challenges. These challenges stem from the requisite involvement of a considerable team of specialized researchers in spinal cord injuries and the logistical intricacies of providing essential resources for in-home rehabilitation, all while accommodating diverse environmental conditions. Regarding sample selection, the study employed a voluntary non-probability sample, so the individuals self-selected to participate in the study, introducing a potential source of bias and potentially impeding the establishment of causal relationships between the intervention and observed outcomes. However, this voluntary sample aligns with specific study criteria, a common practice in medical research. Moreover, to comprehensively evaluate the intervention impact, diverse outcome measures were employed, posing a challenge in isolating specific effects attributable to the intervention. To mitigate this challenge, the study incorporated control samples from both healthy and affected individuals to control for additional environmental influences over time that could impact the results. Conclusions: The HBRP did not demonstrate effectiveness in inducing significant differences in body weight, BMI, and certain anthropometric measurements between pre- and post-assessments. The authors attribute the lack of statistical significance to the brevity of the 6-month intervention period, positing that this duration may be insufficient to counteract the prolonged hiatus from rehabilitation experienced by the participants. Additionally, the challenge posed by the small sample size is acknowledged as a factor influencing the outcomes of such statistical analysis. However, it did yield a substantial impact on these metrics. Moreover, there were notable improvements observed after the program. Additionally, the HBRP has the potential to improve individuals who have been out of regular rehabilitation for several years physically reduce the activity of complications and sometimes even halt their progression. Moreover, these improvements instilled hope and a renewed sense of purpose, motivating them to continue rehabilitation and strive for greater independence and social integration. Therefore, the authors recommend future work to support prolonged rehabilitation programs for individuals with spinal cord injuries, especially those facing interruptions lasting several years. This suggestion is based on our study models, which indicate the effectiveness of rehabilitation even in cases with prolonged interruptions. ;

Related Conditions & MeSH terms

• Rehabilitation
• Spinal Cord Injuries
• Spinal Cord Injury

• NCT number: NCT06230627
• Study type: Interventional
• Source: University of Mosul
• Status: Completed
• Phase: N/A
• Start date: December 21, 2021
• Completion date: March 15, 2023