Effects of a Home-Based Rehabilitation on Anthropometric Measures, Sensory-Motor Functions and Independence After Spinal Cord Injury (HBRSCI)

May 30, 2024 updated by: University of Mosul

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iraq
      • Duhok, Iraq, 00964
        • Munib Abdullah Fathe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HBRP
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 the use of a rubber ball for balance and strength as well as trunk flexibility, static balance, stability, and standing exercises.
Other: Home-based Rehabilitation program
Home-based rehabilitation program The investigators used the ASIA scale to evaluate the sensory function and voluntary movement7. 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 the use of 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.
Other Names:
  • HBRP
Device: Knee-Ankle-Foot-Orthosis
It is used to assist the participant in holding his /her body weight on the lower limb through standing and walking
Other Names:
  • KAFO devices

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anthropometric measurements
Time Frame: Every 6-month repeated measures follow-up for 24 months
The abdominal, pelvic, thigh, and leg circumferences were taken using a tape measure depending on the centimeter (cm) unit from the lying down position. These measures were measured to determine the changes in morphological shape for those parts as a result of home-based rehabilitation for 24 months. This was done using repeated measures that included multiple axes, in addition to others, such as muscle strength. Certain anthropometric measurements, quantified in centimeters, were chosen to monitor alterations arising from the efficacy of the Home-Based Rehabilitation Program (HBRP). These selected measurements comprised Waist/Abdomen circumference, Pelvis circumference, Right/Left Thigh circumference, and Right/Left Leg circumference. Anthropometric parameters, encompassing the circumference of various body segments, were diligently documented through the application of a tape measure.
Every 6-month repeated measures follow-up for 24 months
Weight, height, and body mass index BMI
Time Frame: Every 6-month and follow-up for 24 months
Encompassed weight and body mass index (BMI) was consistently tracked, with specific consideration given to injury-related factors. The height was measured in (cm), and the weight was measured by using traditional scales in (kg). Both weight and height were used to measure the body mass index (BMI). These measures were repeated every 6 months for 24 months to follow up the changes in body weight according to increasing the activity and metabolic in muscles after a home-based rehabilitation program (HBRP).
Every 6-month and follow-up for 24 months
The American Spinal Injury Association ( ASIA) scale
Time Frame: Every 6-month and follow-up for 24 months
It was used to examine the sensory and motor function before and after starting a home-based rehabilitation program (HBRP). The clinical evaluation incorporated the application of the American Spinal Injury Association ( ASIA) scale to measure sensory perception and the potential for voluntary movement, the degree from (0-100) as following the guidelines. Furthermore, the ASIA scale was employed in alignment with an interval of HBRP to appraise participants' sensory and motor function levels to assess the effectiveness of the rehabilitation program, drawing parallels with the methodology utilized. Additionally, ASIA was executed to gauge sensory perception and the capacity for voluntary movement on both sides of the participants' bodies, following the framework outlined.
Every 6-month and follow-up for 24 months
Muscle strength
Time Frame: Every 6-month and follow-up for 24 months

It involved the lower extremity, head, trunk, and pelvis muscle strength tests as a result of HBRP. Muscular strength was assessed in kilograms (kg) for muscles implicated in lower limb activities below the spinal lesion level, muscular strength was appraised for muscles linked to the Head, Trunk, and Pelvis, operating below the level of the spinal lesion. Utilizing the Micro-FET2 dynamometer by HOGGAN, participants exerted maximal force against the device while the examiner applied resistance to gauge muscle strength. These assessments are initiated through verbal commands ("Go" and "Relax").

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.
Every 6-month and follow-up for 24 months
Spinal Cord Independence Measure (SCIM)
Time Frame: Every 6-month repeated measures follow-up for 24 months
The final score ranges from 0 to 100, with a high score indicating a higher independence. A scale was used to assess the level of independence during the 24 months of rehabilitation. This scale involves several items. Its scoring system is self-explanatory; therefore there isn't a manual to instruct the clinician in the scoring process. Scores range from 0-100, where a score of 0 defines total dependence and a score of 100 is indicative of complete independence. Each subscale score is evaluated within the 100-point scale (self-care: 0-20; respiration and sphincter management: 0-40; mobility.
Every 6-month repeated measures follow-up for 24 months
Magnetic resonance imaging (MRI)
Time Frame: 8-9 months after the start of standing and walking training
MRI examinations were performed in the supine position using a hybrid 1.5 T MRI scanner, which is a modified 1.5 T Philips Ingenia. 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) (mm2), 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.
8-9 months after the start of standing and walking training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Mosul

Collaborators

University of Sfax

Investigators

  • Study Chair: Munib A Fathe, PhD, University of Mosul

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2021

Primary Completion (Actual)

October 15, 2021

Study Completion (Actual)

October 25, 2022

Study Registration Dates

First Submitted

May 11, 2024

First Submitted That Met QC Criteria

May 30, 2024

First Posted (Actual)

June 5, 2024

Study Record Updates

Last Update Posted (Actual)

June 5, 2024

Last Update Submitted That Met QC Criteria

May 30, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMosul

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After we complete the publication of this study, we will declare that our data and program will be available by request.

IPD Sharing Time Frame

After publication one month

IPD Sharing Access Criteria

It should be academically study which hold the same interest

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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