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NCT Number: NCT05425238

Blood Flow Restriction Resistance Exercise in Lower Cervical Spinal Cord Injury Patients

This study is conducted to investigate the effects of low load Blood Flow Resistance exercise to improve strength and transfer in lower cervical spinal cord injury patientsCervical Spinal Cord injury patients have very less window of opportunity towards functional mode of life. In complete cervical spinal cord injuries only few muscles of upper limb are completely innervated and it is a need to gain maximum output and advantage out of that. Through conventional strength training it is possible to make him do unsupported sitting and transfer But with BFR-RE it may have a possibility to do this procedure in less time than the conventional strength training and patient will save cost of hospital stay as he may timely discharge from hospital early

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Key information

Conditions

Cervical Spinal Cord Injury

Age range

15 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lahore general Hospital

Lahore, Punjab Province, 54000, Pakistan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Both male and female, with age between 16-50 years.
  • Patients evaluated with C6 to C8 tetraplegic complete injury.
  • Patients classified in ASIA A, ASIA B.
  • At least Muscle grading of grade 2.
  • Patients with sub-acute, chronic stage.

Exclusion criteria

  • Patients with other neurologic conditions, orthopedic problems, and uncontrolled metabolic diseases.
  • Patients with muscles strength grading of less than 2.
  • Undergone nerve transfer surgery.
  • Patients with acute stage.
  • History of DVT.
  • Patients who are already performing structured physical activities such as muscle Strengthening exercises.

Treatment and study plan

Blood Flow Restriction

Other

strengthening protocol but with Blood flow restriction technique

.Standard BFR Application: a standard pressure (used for all patients) for e.g. 180

mmHg; a pressure relative to the patient's systolic blood pressure, for e.g. 1.2 - or 1.5-fold greater than systolic blood pressure.40% cuff pressure as percentage of LOP.(4) And performing BFR-RE with low load exercises. So 30% of 1 RPM would be enough 4 times a week for 6 week

Conventional physical therapy

Other

Resistance exercise 75 repetitions across four sets of exercises, with30 repetitions in the first set and 15 repetitions in each subsequent set. 4 times a week for 6

Primary outcomes

  1. VAS- Visual Analogue Scale

    Time frame: 6th week

    To measure the intensity of pain

  2. MAS- Modified Ashworth Scale

    Time frame: 6th week

    To measure the muscular hypertrophy and increased tone. Usually used to measure increased tone in spasticity but also used to measure hypertrophy resulted from normal muscles adaptations.

  3. QIF-SF -- Quadriplegia Index Of Functionality-Small Form

    Time frame: 6th week

    To the transfer and functional ability in tetraplegic patients.

  4. Hand Held Dynamometer

    Time frame: 6th week

    To measure the strength objectively and To measure the minor but notable changes in strength change which cannot be detected by MMT

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Blood Flow Restriction Resistance Exercise on Strength and Transfer in Lower Cervical Spinal Cord Injury Patients

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 21, 2022
Registry last updated
Jul 20, 2023

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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