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Completed

NCT Number: NCT04358679

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

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

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Key information

Conditions

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

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Paraplegic Center Peshawar

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

conventional treatment

Other

Conventional Treatment:

  • Deep breathing: 10-15 reps, twice a day (BD)
  • Assisted coughing 10-15 reps, BD
  • range of motion (ROM)+ stretching 10 reps, BD
  • Tilt table standing

Upper Limb ergometer training

Other

Conventional Treatment + upper limb (UL) ergometry exercise UL ergometry exercise 15 to 20 mints , 2 times ,five days per week for 6 weeks.

Primary outcomes

  1. 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

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Apr 24, 2020
Registry last updated
Apr 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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