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

Cervical Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05425238
• Other study ID #: REC/RCR&AHS/22/0222
• Status: Completed
• Phase: N/A
• Start date: May 15, 2022
• Est. completion date: December 15, 2022

Study information

• Verified date: July 2023
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 15, 2022
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Spinal Cord Injury
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

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
• 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

Locations

Country	Name	City	State
Pakistan	Lahore general Hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (9)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

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