Clinical trial NCT06444672: Effects of a Home-Based Rehabilitation on Anthropometric Measures, Sensory-Motor Functions and Independence After Spinal Cord Injury
Official title: Effects of a Home-Based Rehabilitation on Anthropometric Measures, Sensory-Motor Functions and Independence After Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury at T7-T10 Level
War Injuries Due to Bullets and Fragments
Spinal Cord Injury L1- L5
Spinal Cord Injury No Sensory/Motor in S4-S5
Keywords: Spinal cord Injury
Anthropometric Measures
Muscles Strength
Motor-Sensory Functions
Home-Based Rehabilitation
Lead sponsor: University of Mosul
Sponsor class: OTHER
Collaborators: name: University of Sfax
First posted: 2024-06-05
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 23
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Serial case study in a quasi-experimental design
Primary purpose: TREATMENT

Brief summary: Background: The scarcity of resources for spinal cord injury (SCI) rehabilitation constitutes a significant obstacle, particularly in war-torn regions experiencing a rise in such injuries. Implementing a home-based rehabilitative program (HBRP) tailored to patients' environmental, social, and financial contexts is crucial in mitigating this challenge. The authors investigated the effects of a 24-month HBRP on anthropometric measurements, muscular strength, sensory and motor function, and independence in participants transitioning from bed to walking following SCI.

Methods: Serial case study in a quasi-experimental design, the conducting was at the participants' homes. The participants were four patients with SCI (experimental group) and another two patients with SCI (control group). The interventions were a 24-month HBRP comprising strength, flexibility, and balance training, the outcome measures involved anthropometric measurements, muscle strength using a digital handheld dynamometer, muscle thickness, and cross-sectional area measured using magnetic resonance imaging, measured five walking tests, and the American Spinal Injury Association scale (ASIA) score for assess the sensory and motor score, and the Spinal Cord Independence Measure (SCIM).

Detailed description: Materials and Methods

The primary condition being studied:

Spinal Cord Injury Paraplegia according to ASIA-scale Type A Complete damage No Sensory/Motor in S4-5

Participants

From (NRCODP), the authors accessed six participants with SCIs who participated voluntarily in this study (three males and one female; their mean age was 24.75 years). Those patients constituted the experimental group. Their injuries were classified as grade A according to the American Spinal Injury Association (ASIA) scale. Spinal cord damage was observed at T6, T8, L1, and L2. The participants started receiving the HBRP intervention 4-6 months after injury and the program lasted 24 months. The control group comprised two volunteers (mean age 23.50 years) with SCIs at T9 and L1. These patients only served as a comparison for magnetic resonance imaging (MRI) findings.

This study was a case series that included a home-based therapeutic exercise program. Strength and ASIA- scales were assessed every 6 months. The walking evaluation was performed monthly for 10 months after the participants began using assistive devices. The final assessment was conducted at 24 months.

Home-based rehabilitation program The investigators used the ASIA scale to evaluate sensory function and voluntary movement. The HBRP included whole-body training with various exercises for stretching, strength, endurance, and aerobic fitness. The treatment sessions were performed three times per week and had a 50-120-minute duration. The exercises were modified based on individual progress and included using a rubber ball for balance and strength, as well as trunk flexibility, static balance, stability, and standing exercises. Participants who could stand with assistive devices such as knee-ankle-foot orthoses (KAFO) performed walking exercises. During the 24 months, the program encountered technical obstacles during implementation, primarily related to the unavailability of suitable tools to optimize exercise performance while ensuring participant safety, especially during the first 6 months. Precautionary measures included creating a secure exercise environment within a furniture-free 2-meter square, employing safety belts, maintaining a safe distance, and involving participants' relatives for assistance, especially during the introduction of new and challenging motor tasks. Participants' families either purchased or received exercise equipment, and some devices were locally manufactured based on standard specifications. Participants facing negative psychological states due to motor challenges and monotony received psychological, faith-based, encouraging, and entertaining interventions, incorporating real-life success stories through video observations of individuals with SCIs. During the 24 months, the program encountered technical obstacles during implementation, primarily related to the unavailability of suitable tools to optimize exercise performance while ensuring participant safety, especially during the first 6 months. However, precautionary measures included creating a secure exercise environment within a furniture-free 2-meter square, employing safety belts, maintaining a safe distance, and involving participants' relatives for assistance, especially during the introduction of new and challenging motor tasks. Participants' families either purchased or received exercise equipment, and some devices were locally manufactured based on standard specifications. Participants facing negative psychological states due to motor challenges and monotony received psychological, faith-based, encouraging, and entertaining interventions, incorporating real-life success stories through video observations of individuals with SCIs.

Walking tests. The 10-m walk test (WT), 2-min WT (2MWT), 4MWT, 6MWT, and Up \& GO (WT) were used when the participants reached the walking phase. These tests were used to assess walking speed improvement and endurance in patients with SCI. The investigators chose wide, suitable areas at participants' homes for walking assessments to adhere to test prerequisites. Essential equipment, including markers denoting starting and concluding points, was supplied and distinguished "Remember the following text: 'by colorful stickers'", stopwatches, and measuring tapes. Further, safety protocols were implemented to safeguard participants during test execution, and all tests were carried out according to the relevant standards.

In addition, a kinesthetic analysis approach was used, in which mental visualization played a pivotal role in patients who lack a sense of balance. Locally manufactured assistive devices (e.g., KAFO) were used, and coordination between doctors and the author ensured effective treatment and successful rehabilitation.

Outcome measures Anthropometric measurements, including the abdominal, pelvic, thigh, and leg circumference, were taken using a tape measure. Weight and height were measured using traditional scales. Patient measurements (weight, body mass index \[BMI\], and anthropometric measurements) were monitored every 6 months throughout the intervention period. The ASIA scale was used to examine the sensory and motor function before stating HBRP and subsequently every 6 months. The pre-HRBP and 24-month values were also compared. In addition, muscle strength was measured using a Micro-FET2 dynamometer (Hoggan Scientific LLC, Salt Lake City, UT), where the participants exerted maximum force against the device while the examiner provided resistance. The tests lasted a few seconds and were signalled by the commands "go" and "relax". The Spinal Cord Independence Measure (SCIM) includes the self-care (0-20), respiration and sphincter management (0-40), and mobility (0-40) sub-scores. Each area is scored according to its proportional weight in these patients' general activity. The final score ranges from 0 to 100, with a high score indicating higher independence, the authors assess the independence of participants during the 24 months of rehabilitation.

Magnetic resonance imaging technical considerations MRI examinations were performed in the supine position using a hybrid 1.5 T MRI scanner (Elekta Unity™, Philips, Stockholm, Sweden), which is a modified 1.5 T Philips Ingenia (Best, The Netherlands). Long stair and T1 fat suppression sequences were used to investigate the utility of MRI in measuring changes in muscle volume, and anatomical cross-sectional area (CSA), focusing on the rectus femoris (RF) and gluteus maximus (GM) muscles. Additionally, the MRIs included muscle thickness (MT) in (mm) and CSA measurements for the bilateral RF and GM muscles. These measurements were repeated 8-9 months after the start of standing and walking training. Previous research has already established the reliability and validity of MRI for measuring MT and its capability to detect and monitor muscle changes during immobilization.

During MRI analysis, the initial peak corresponds to muscle density, while the subsequent peak indicates fat density, and the midpoint between these peaks delineates muscle from fat pixels. Calculations of CSAs were performed using the equations outlined by Gorge and Dudley. Muscle CSA (cm2) = ¼ of the total number of muscle pixels \* (\[field of view {FOV} / matrix size\])2, and Intramuscular Fat (IMF) CSA (cm2) = ¼ of the total number of IMF pixels \* (\[FOV / matrix size\])2. To normalize for skeletal muscle size discrepancies across groups, IMF CSA was expressed relative to skeletal muscle CSA: Relative IMF = ¼ of (\[IMF CSA / muscle CSA\] \* 100).

Statistical analysis Study outcomes were compared across time points using a one-way repeated-measures analysis of variance. The ES was quantified by Cohen's criteria. Additionally, paired sample t-tests were used to compare pre-and post-intervention MRI measures and ASIA scale scores. SPSS version 24.0 (IBM Corp., Armonk, NY, USA) was used for all analyses. An alpha value \<0.05 indicated statistical significance.

Eligibility criteria: Inclusion Criteria:

* Every patient has SCI resulting from the ISIS war and HE/SHE committed to implementing the HBRP without interruption and implements all instructions from the researcher supervising the program.

Exclusion Criteria:

* If any information and conditions above are not available.

Primary outcomes:
measure: Anthropometric measurements
timeFrame: Every 6-month repeated measures follow-up for 24 months
measure: Weight, height, and body mass index BMI
timeFrame: Every 6-month and follow-up for 24 months
measure: The American Spinal Injury Association ( ASIA) scale
timeFrame: Every 6-month and follow-up for 24 months
measure: Muscle strength
timeFrame: Every 6-month and follow-up for 24 months
measure: Spinal Cord Independence Measure (SCIM)
timeFrame: Every 6-month repeated measures follow-up for 24 months
measure: Magnetic resonance imaging (MRI)
timeFrame: 8-9 months after the start of standing and walking training
Secondary outcomes:
Other outcomes:
Locations:
city: Duhok
country: Iraq
facility: Munib Abdullah Fathe
Study officials:
affiliation: University of Mosul
name: Munib A Fathe, PhD
role: STUDY_CHAIR
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