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

July 18, 2023 updated by: Riphah International University

Effects of Blood Flow Restriction Resistance Exercise on Strength and Transfer 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Spinal cord injury is the major concern which can lead to severe impairments and lead to disability. Cervical spinal cord complete injuries patients have a very narrow window of opportunity and we have to gain maximum output and advantage out of that. C6 tetraplegic patients have muscles innervations limited to some groups of upper limb. Even triceps are not innervated in c6 tetraplegic complete injury. However we use special techniques and strengthening of innervated muscles to make him able doing unsupported sitting and transfer from bed to wheel chair. Normally to attain strengthening in a muscle group is achieved by up to 80% of 1 RM. But the spinal cord population cannot endure such heavy loads and has high risk of DVT. So on the safe side clinicians and researches use 30% to 60% 1 RM.

In our study there are two equally distributed groups of complete tetraplegic patients. One will attain strengthening with low load resistance training which conventional training program And Other will attain strengthening with Blood Flow Restriction Resistance Exercise technique with Low Loads in Short, the aim of this study is to test the use of Blood flow restriction - Resistance exercise with low loads as a surrogate for high loads conventional training for strength. BFR Pressure for tourniquet will be 1.2 to 1.5 folds greater than the SBP depending on the AOP. Exercise Guidelines for both group will be 75 repetitions in 4 sets at 4 days a week for 6 weeks. Data will be collected at 0 week and after 6 weeks also. As well as after 15 days date will be collected to see minor but notable changes in strength and hypertrophy. The tools we will use are: VAS- Visual Analogue Scale, MAS- Modified Ashworth Scale, QIF-SF -- Quadriplegia Index Of Functionality- Small Form, Hand Held Dynamometer, Manual muscle testing. The data will be analyzed using SPSS software version 25.0

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Lahore general hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Blood flow restriction
Resistance training 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.
Other: Blood flow restriction

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
Active Comparator: Conventional physical therapy
Resistance training to stimulate skeletal muscle hypertrophy and strength adaptations in Duration of 6 weeks
Other: Conventional physical therapy
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS- Visual Analogue Scale
Time Frame: 6th week
To measure the intensity of pain
6th week
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.
6th week
QIF-SF -- Quadriplegia Index Of Functionality-Small Form
Time Frame: 6th week
To the transfer and functional ability in tetraplegic patients.
6th week
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
6th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Binash Afzal, PHD*, Riphah international university lahore campus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2022

Primary Completion (Actual)

November 15, 2022

Study Completion (Actual)

December 15, 2022

Study Registration Dates

First Submitted

June 15, 2022

First Submitted That Met QC Criteria

June 15, 2022

First Posted (Actual)

June 21, 2022

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR&AHS/22/0222

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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