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Cervical Spinal Cord InjuryNCT05425238

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

A study testing Blood flow restriction and Conventional physical therapy in people with Cervical Spinal Cord Injury, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 15 to 50 years
Conditions the study is for
Cervical Spinal Cord Injury
What is being tested?
Blood flow restriction and Conventional physical therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 sitePakistan
Study dates
15 May 2022to 15 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 50 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Lahore general Hospital

    Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

Official title: 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

Being tested
Blood flow restriction, Conventional physical therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood flow restrictionOther

    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 therapyOther

    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

Study groups in NCT05425238
Study groupRoleWhat they receive
Blood flow restrictionExperimentalResistance 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.
Receives: Other: Blood flow restriction
Conventional physical therapyActive comparatorResistance training to stimulate skeletal muscle hypertrophy and strength adaptations in Duration of 6 weeks
Receives: Other: Conventional physical therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. VAS- Visual Analogue Scale

    To measure the intensity of pain

    Measured: 6th week

  2. 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.

    Measured: 6th week

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

    To the transfer and functional ability in tetraplegic patients.

    Measured: 6th week

  4. 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

    Measured: 6th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2022
  2. Study start15 May 2022
  3. Primary completion15 Nov 2022
  4. Study completion15 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05425238
Sponsor's protocol ID
REC/RCR&AHS/22/0222
Status last verified
Jul 2023
First submitted
15 Jun 2022
Last updated
20 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27815685

  • 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.

    PubMed 23527771

  • 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.

    PubMed 21922259

  • 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.

    PubMed 28259850

  • 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.

    PubMed 25491331

  • 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.

    PubMed 18581660

  • 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.

    PubMed 34783737

  • 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.

    PubMed 31156448

  • 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.

    PubMed 16717321

Questions about this trial

What is this clinical trial studying?

A study testing Blood flow restriction and Conventional physical therapy in people with Cervical Spinal Cord Injury, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

VAS- Visual Analogue Scale (time frame: 6th week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05425238, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.

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