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Clinical Trials/NCT04358679
NCT04358679CompletedNot Applicable

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

Riphah International University2 sites in 1 country44 target enrollmentStarted: September 1, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
44
Locations
2
Primary Endpoint
Forced vital Capacity (FVC)

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
25 Years to 45 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • SCI at level of upper and lower thoracic spine

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)

Outcomes

Primary Outcomes

Forced vital Capacity (FVC)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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