Upper Limb Ergometer on Pulmonary Function Among Patients With Spinal Cord Injury.

Not Applicable

Completed

• Conditions: Spinal Cord Injuries
• Interventions: Other: Conventional Treatment; Other: Upper Limb ergometer training

• Registration Number: NCT04358679
• Lead Sponsor: Riphah International University

Brief Summary

Randomized Control Trial, To determine the effects of arm ergometer exercise on pulmonary function of Spinal Cord Injury.

Detailed Description

The spinal cord is a tubular structure contained nervous tissue. This acts as a transmission channel of nerve signals within the brain and spinal cord. It contains grey and white matter. The grey matter consists of cell bodies of different sensory and motor neurons and white matter consists of oriented spinal tracts.

By 2007, a prospective observational study had been conducted after a disaster occurred in Pakistan which was the most cataclysmic natural disaster in country's history as a result 73000 people were lost their lives and 126000 were harmed. There was no Spinal Cord Injury (SCI) registry existed in the country but according to different estimates 650-750 had been effected of SCI.

In United States SCI incidence mainly due to higher percentage of violence-related SCIs (18%)which is higher compared to the western Europe (8%) Australia (2%). In Pakistan the most common traumatic cause of SCI was falling from different cause followed by road traffic accident (RAT) (25.2%) and functional aerobic impairment (FAI) (8.4%). The way that SCI is associated with fantastic expenses and human sufferings , yet careful statistics of SCI are not accessible in dominant of developing countries including Pakistan.

Total lung capacities become abnormal in chronic spinal cord injury patients. Changes in chest wall compliance and decreased respiratory muscle strength leads to abnormal changes in overall lung capacities.

Study Timeline

• Study Start: 2019-09-01
• Primary Completion: 2019-12-30
• Study Completion: 2020-01-10
• Status Verified: 2020-04
• Study First Submitted: 2020-04-20
• Study First Submitted QC: 2020-04-20
• Last Update Submitted: 2020-04-20
• Study First Posted: 2020-04-24
• Last Update Posted: 2020-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• SCI at level of upper and lower thoracic spine

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Exclusion Criteria

• Cardiovascular diseases
• Active inflammation or infection going in body
• Malignancies
• Those Individuals with have psychiatric disorders
• Any other neurological condition related to brain (stroke, parkinson's etc)
• Pressure ulcers (grade 3 and grade 4)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Treatment	Conventional Treatment	Conventional Treatment: Deep breathing, Assisted coughing, Sustained stretching, Splinting, Bracing and Functional mobility
Upper Limb ergometer training	Upper Limb ergometer training	Conventional Treatment + Upper Limb (UL) ergo-meter exercise

Primary Outcome Measures

Name	Time	Method
Forced vital Capacity (FVC)	6 Week	Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters
Peak Expiratory Flow (PEF)	6 Week	Changes from the Baseline, the digital spirometer is used in clinical setting to analyze peak expiratory flow PEF in Liter/second.
Forced Expiratory Volume in 1 second (FEV1)	6 Week	Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters

Trial Locations

Locations (1)

Paraplegic Center Peshawar; 🇵🇰 Peshawar, Khyber Pakhtunkhwa, Pakistan