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

NCT06444672 | Completed DMC

• 1 other identifier: UMosul
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (6)

• Anthropometric measurements

  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

  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

  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

  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)

  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)

  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

Study Arms (1)

HBRP

EXPERIMENTAL

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; Device: Knee-Ankle-Foot-Orthosis

Interventions

Home-based Rehabilitation program OTHER

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.

Also known as: HBRP

HBRP

Knee-Ankle-Foot-Orthosis DEVICE

It is used to assist the participant in holding his /her body weight on the lower limb through standing and walking

Also known as: KAFO devices

HBRP

Eligibility Criteria

• Age: 18 Years - 23 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• If any information and conditions above are not available.

Sponsors & Collaborators

• University of Mosul: lead
• University of Sfax: collaborator

Study Sites (1)

Munib Abdullah Fathe

Duhok, 00964, Iraq

Location

Related Publications (19)

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MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Munib A Fathe, PhD

  University of Mosul

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Home-based rehabilitation program We used ASIA-scale to evaluate 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-min 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Serial case study in a quasi-experimental design

Study Record Dates

• First Submitted: May 11, 2024
• First Posted: June 5, 2024
• Study Start: September 25, 2021
• Primary Completion: October 15, 2021
• Study Completion: October 25, 2022
• Last Updated: June 5, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After publication one month
• Access Criteria: It should be academically study which hold the same interest

Locations

IR (1)