Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06230627 |
Other study ID # |
University of Mosul |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
December 21, 2021 |
Est. completion date |
March 15, 2023 |
Study information
Verified date |
January 2024 |
Source |
University of Mosul |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
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.
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.