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

Primary Purpose

Cervical Spinal Cord Injury

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Blood flow restriction
Conventional physical therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Spinal Cord Injury

Eligibility Criteria

15 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Lahore general Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Blood flow restriction

Conventional physical therapy

Arm Description

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.

Resistance training to stimulate skeletal muscle hypertrophy and strength adaptations in Duration of 6 weeks

Outcomes

Primary Outcome Measures

VAS- Visual Analogue Scale
To measure the intensity of pain
MAS- Modified Ashworth Scale
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.
QIF-SF -- Quadriplegia Index Of Functionality-Small Form
To the transfer and functional ability in tetraplegic patients.
Hand Held Dynamometer
To measure the strength objectively and To measure the minor but notable changes in strength change which cannot be detected by MMT

Secondary Outcome Measures

Full Information

First Posted
June 15, 2022
Last Updated
July 18, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05425238
Brief Title
Blood Flow Restriction Resistance Exercise in Lower Cervical Spinal Cord Injury Patients
Official Title
Effects of Blood Flow Restriction Resistance Exercise on Strength and Transfer in Lower Cervical Spinal Cord Injury Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
May 15, 2022 (Actual)
Primary Completion Date
November 15, 2022 (Actual)
Study Completion Date
December 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Spinal Cord Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blood flow restriction
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional physical therapy
Arm Type
Active Comparator
Arm Description
Resistance training to stimulate skeletal muscle hypertrophy and strength adaptations in Duration of 6 weeks
Intervention Type
Other
Intervention Name(s)
Blood flow restriction
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Conventional physical therapy
Intervention Description
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 Outcome Measure Information:
Title
VAS- Visual Analogue Scale
Description
To measure the intensity of pain
Time Frame
6th week
Title
MAS- Modified Ashworth Scale
Description
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.
Time Frame
6th week
Title
QIF-SF -- Quadriplegia Index Of Functionality-Small Form
Description
To the transfer and functional ability in tetraplegic patients.
Time Frame
6th week
Title
Hand Held Dynamometer
Description
To measure the strength objectively and To measure the minor but notable changes in strength change which cannot be detected by MMT
Time Frame
6th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Binash Afzal, PHD*
Organizational Affiliation
Riphah international university lahore campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lahore general Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27815685
Citation
Roberts TT, Leonard GR, Cepela DJ. Classifications In Brief: American Spinal Injury Association (ASIA) Impairment Scale. Clin Orthop Relat Res. 2017 May;475(5):1499-1504. doi: 10.1007/s11999-016-5133-4. Epub 2016 Nov 4. No abstract available.
Results Reference
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PubMed Identifier
23527771
Citation
Kozlowski AJ, Heinemann AW. Using individual growth curve models to predict recovery and activities of daily living after spinal cord injury: an SCIRehab project study. Arch Phys Med Rehabil. 2013 Apr;94(4 Suppl):S154-64.e1-4. doi: 10.1016/j.apmr.2012.11.050.
Results Reference
background
PubMed Identifier
21922259
Citation
Loenneke JP, Wilson JM, Marin PJ, Zourdos MC, Bemben MG. Low intensity blood flow restriction training: a meta-analysis. Eur J Appl Physiol. 2012 May;112(5):1849-59. doi: 10.1007/s00421-011-2167-x. Epub 2011 Sep 16.
Results Reference
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PubMed Identifier
28259850
Citation
Hughes L, Paton B, Rosenblatt B, Gissane C, Patterson SD. Blood flow restriction training in clinical musculoskeletal rehabilitation: a systematic review and meta-analysis. Br J Sports Med. 2017 Jul;51(13):1003-1011. doi: 10.1136/bjsports-2016-097071. Epub 2017 Mar 4.
Results Reference
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PubMed Identifier
25491331
Citation
Yasuda T, Fukumura K, Iida H, Nakajima T. Effect of low-load resistance exercise with and without blood flow restriction to volitional fatigue on muscle swelling. Eur J Appl Physiol. 2015 May;115(5):919-26. doi: 10.1007/s00421-014-3073-9. Epub 2014 Dec 10.
Results Reference
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PubMed Identifier
18581660
Citation
Anderson K, Aito S, Atkins M, Biering-Sorensen F, Charlifue S, Curt A, Ditunno J, Glass C, Marino R, Marshall R, Mulcahey MJ, Post M, Savic G, Scivoletto G, Catz A; Functional Recovery Outcome Measures Work Group. Functional recovery measures for spinal cord injury: an evidence-based review for clinical practice and research. J Spinal Cord Med. 2008;31(2):133-44. doi: 10.1080/10790268.2008.11760704.
Results Reference
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PubMed Identifier
34783737
Citation
Perwaiz S, Afzal MW, Fatima G. Comparison between qualitative and quantitative measurement of strength deficit in shoulder flexors of young females: A cross- sectional study. J Pak Med Assoc. 2021 Nov;71(11):2559-2562. doi: 10.47391/JPMA.011431.
Results Reference
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PubMed Identifier
31156448
Citation
Patterson SD, Hughes L, Warmington S, Burr J, Scott BR, Owens J, Abe T, Nielsen JL, Libardi CA, Laurentino G, Neto GR, Brandner C, Martin-Hernandez J, Loenneke J. Blood Flow Restriction Exercise: Considerations of Methodology, Application, and Safety. Front Physiol. 2019 May 15;10:533. doi: 10.3389/fphys.2019.00533. eCollection 2019. Erratum In: Front Physiol. 2019 Oct 22;10:1332.
Results Reference
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PubMed Identifier
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Citation
Tuncali B, Karci A, Tuncali BE, Mavioglu O, Ozkan M, Bacakoglu AK, Baydur H, Ekin A, Elar Z. A new method for estimating arterial occlusion pressure in optimizing pneumatic tourniquet inflation pressure. Anesth Analg. 2006 Jun;102(6):1752-7. doi: 10.1213/01.ane.0000209018.00998.24.
Results Reference
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Blood Flow Restriction Resistance Exercise in Lower Cervical Spinal Cord Injury Patients

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