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Incomplete Spinal Cord InjuryNCT05491837

Device-induced Intermittent Hypoxia in Persons With Incomplete Spinal Cord Injury

A study testing Device induce acute intermittent hypoxia 9 % of Oxygen and Normoxia 21% of oxygen in people with Incomplete 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

Spinal cord injury (SCI) is a devastating disability with physical, social and vocational consequences. Owing to its overwhelming complications, the cost of treatment and rehabilitation increases constantly. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Incomplete Spinal Cord Injury
What is being tested?
Device induce acute intermittent hypoxia 9 % of Oxygen and Normoxia 21% of oxygen
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
68 participants
Where
1 sitePakistan
Study dates
6 Mar 2023to 5 Apr 2024
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Incomplete SCI≥ 3 months(21);
  • Traumatic and non-traumatic, non-progressive lesions, Aged ≥ 18 years ;
  • LesionC4 and below as classified ASIA category C and D;
  • Both gender
  • Ability to ambulate with or without assistive devices; and
  • Ability to follow verbal and visual command.

Who cannot join

  • Participants with complete spinal cord injury;
  • Unstable orthopedic injuries and joint contractures
  • Osteoporosis with high risk of fracture;
  • Pressure ulcers and cutaneous lesion(4)
  • Cognitive impairment, severe cardiopulmonary complication such as severe breathing disorder

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Riphah International University Islamabad

    Islamabad, 44000

Other trials in Pakistan

About this study

Official title: Effects of Device Induced Acute Intermittent Hypoxia in Upper and Lower Limb Activity Functions in Persons With Incomplete Spinal Cord Injury.

Spinal cord injury (SCI) is a devastating disability with physical, social and vocational consequences. Owing to its overwhelming complications, the cost of treatment and rehabilitation increases constantly. Persons with spinal cord injury are always dependent on their families in most of house hold, recreational and activities of daily life. Majority of SCI are incomplete classification C or D as per American spinal injury Association (ASIA). Due to certain spared pathways intrinsic mechanism of neuroplasticity take place in incomplete spinal cord injuries (iSCI) which is liable for natural recovery, but this potential is limited and often slow. Therefore there is need for some advance therapeutic interventions which may enhance neuroplasticity and improve functional recovery in individuals with iSCI.

It has been reported that acute intermittent hypoxia (AIH) increase neuro plasticity by causing release of spinal serotonin which stimulate serotonin type 2 (5-HT2) receptors that undergoes a series of mechanisms which increase brain derived neurotrophic factors (BDNF) which subsequently enhance motor functions of upper and lower limbs in iSCI.

Despite of the growing body of literatures supporting that AIH improves both upper limb and lower limb functions along with walking ability and speed. However, their results are limited to small sample size, gender biased and lack of intralimbs assessment. As per the author knowledge, these literatures lack retention effects of AIH on upper and lower limb function. In addition variables like quality of life, disability and some biomarkers related to hypoxic effects have not been reported in any of these studies. Furthermore, it is hypothesized that variant geographic locations and socioeconomic status may affects persons with iSCI differently. So in light of these literature gaps, the author aim is to investigate the effects of AIH in upper and lower limb motor function, balance, quality of life and disability. In addition, the effects of AIH on brain derived neurotrophic factors (BDNF), hemoglobin (Hb) level, numbers of RBS and hematocrits will be assessed.

Being tested
Device induce acute intermittent hypoxia 9 % of Oxygen, Normoxia 21% of oxygen

What participants receive

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

  • Device induce acute intermittent hypoxia 9 % of OxygenOther

    Interventional group will be provided a brief sequence of mild hypoxia consisting of 9% oxygen for one minute followed by normoxia 21% of oxygen for a total of 15 episodes

  • Normoxia 21% of oxygenOther

    SHAM group will be provided normoxia 21% of Oxygen

Study groups in NCT05491837
Study groupRoleWhat they receive
Interventional groupExperimentalThe interventional group will be provided a brief sequence of acute hypoxia consisting of 9% oxygen via device HYP 123 or a certified JAY-10H hypoxic generator (LONGFIAN SCITEC CO., LTD, Registration #AE 50424841-0001) for one minute, followed by normoxia 21% of oxygen for a total of 15 repetitions. These protocols will be provided 5 times/week for the first week and then 3 times per week for the rest of the 3 weeks.
Receives: Other: Device induce acute intermittent hypoxia 9 % of Oxygen; Other: Normoxia 21% of oxygen
Control groupSham comparatorSHAM group' participants will be provided 21% of O2 (normoxia), comprised of 15 repetitions of 1-minute then switching to another 1-minute of 21% O2. This protocols will be provided 3 times/week for a period of 4 weeks.
Receives: Other: Normoxia 21% of oxygen

What is being measured

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

  1. Upper limb function

    Change in upper limb function will be assessed via the Box and Block test (BBT). The BBT is used to test manual dexterity. The participants are requested to move a 1-inch block from one box to another in 60 seconds while crossing the partition between the boxes. The total blocks moved will be calculated as the test score.

    Measured: change will be assessed on base line before intervention, post 7 days, post 14 days, post 21 days, post 30 days and a follow up week without intervention for retention effects

  2. upper limb grip strength

    change in Grip strength will be measured by using hand dynamometer (Model-Jamardigital Hand dynamometer). Participants will be seated with shoulder adducted and neutral rotated, elbow at 90 degree position. The forearm is in between supination and pronation without support of arm rest and the wrist is in neutral position. Maximum contraction will be measured by asking the participants to contract against the hand grip while maintaining the contraction for 3 to 5 seconds. Average of 3 attempts will be calculated as measurement

    Measured: change in grip strength will be assessed on base line before intervention, post 7 days, post 14 days, post 21 days, post 30 days and a follow up week without intervention for retention effects

  3. Quick DASH to measure upper limb disability

    Quick Disability of arm, shoulder and Hand (DASH) questionnaire is a self-reporting 11-items questionnaire that measures the ability of patients to perform certain upper limb tasks. The patients can rate their difficulty that they may face during specific upper limb activity on 5 points likert scale. The questionnaire is designed to assess one or more disability of arm shoulder and hand. It has good validity and reliability. The interclass correlation coefficient (ICC) is 0.82 The test retest reliability of the both 11 item and its optional work 15 items are 0.9 and 0.94 respectively and that neither of them are significant difference from that of the original DASH questionnaire

    Measured: It will be assed on baseline and after 4 week of interventions

  4. walking performance

    Change in walking performance will be assessed via 10 meter 'walk test(10MWT). It is used to assess walking performance of individual. It measures times in seconds the participants is taken during 10 meters of walking as quickly as possible using their regular devices. This scale has been validated for iSCI and its test retest, intra-rater are excellent (r= 0.983) while inter-rater r=0.97.

    The Time up and go test (TUG)is used to evaluate the walking performance of an individual that he takes to stand up from chair and walk 3 meters independently with her/his own pace of walking. Then return to resume his seated position again. Total time in seconds will be calculated. This scale has excellent validity and both test retest and intra rater reliability r=0.98 while inter-rater reliability reported as r=0.97.

    Measured: change in walking performance will be measured on base line before intervention, post 7 days, post 14 days, post 21 days, post 30 days and a follow up week without intervention for retention effects

  5. walking endurance

    Chane in walking endurance will be measured via 6 minute walk test. This scale is validated for patients with iSCI with an excellent inter rater reliability r- 0.98. The participants are advised to walk 6 minutes as far as possible in 6 minutes while total distance in meters is calculated. Participants can rest if needed but they are advised not to sit

    Measured: change will be assessed on base line before intervention, post 7 days, post 14 days, post 21 days, post 30 days and a follow up week without intervention for retention effects

  6. lower limb muscle strength

    Lower limb dynamometer is used to quantify strength of lower limb muscles. It assesses isometric strength of lower limb muscles and considered a suitable alternative of conventional manual muscle testing.

    Measured: change in lower limb strength be assessed on base line before intervention, post 7 days, post 14 days, post 21 days, post 30 days and a follow up week without intervention for retention effects

  7. balance

    The berg balance scale(BBS) was originally developed for stroke and geriatric population but it's used is also evident in iSCI(40). It is 14-items scale that is used to assess static balance and fall risk in adults. It has been used in various neurological disorders. In incomplete spinal cord injury, it is reported that BBS has excellent inter-observer reliability both for single item and for total items r =.84 and ICC =0.95 (41). The concurrent validated of BBS in regard to spinal cord injury is also reported moderate to high (40). The BBS total score is 56 and less than 45 indicated risk of fall

    Measured: change in the balance score will be assessed on baseline before intervention, and after 4 weeks of intervention

  8. Brain derived Neurotrophic factors (BDNF) to measure plasticity in brain

    Brain derived neurotrophic factors are secreted by the neuron which is one of the important factors in neural plasticity. Effects of various locomotor exercise in incomplete spinal cord injury have been investigated. It is premised that BDNF activate high affinity tropomyosin related kinase receptor subtype B (TrKB) also called tyorosin kinase B that help in rhythmic activity of diagram in cervical incomplete spinal cord injury. In human, BDNFis present in blood platelets where it starts accumulating during synthesis of megakaryocytes. It can be readily detectable in human serum by ELIZA using monoclonal antibodies and thus it is considered reliable and has been largely speculated that it may improve brain functions

    Measured: It will be assed on baseline and after 4 week of interventions

Secondary outcomes (1)

  1. WHO QOL Urdu version to assess quality of life

    WHOQOL-BREF is a short version of WHOQOL-100. It is widely used quality of life questionnaire in various conditions and applicable cross culturally. It comprises of four domains each incorporated with various facets to form 26 questions in total. It has been shown that its internal consistency is good Cronbach α range 0.74-o.78 in spinal cord injury

    Measured: It will be assed on baseline and after 4 week of interventions

Timeline

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

  1. First posted8 Aug 2022
  2. Study start6 Mar 2023
  3. Primary completion5 Apr 2024
  4. Study completion5 Apr 2024

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
Model description
The participants are randomly divided into 2 groups. Interventional and SHAM
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05491837
Sponsor's protocol ID
RIPHAH/RCRS/REC/Letter-0129
Status last verified
May 2026
First submitted
24 Jul 2022
Last updated
22 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: At this stage IPD is No. Once the data collection process is started and individual consent form including their permission for publication of the data is taken. Then IPD will be shared accordingly.

Publications

  • Ahuja CS, Wilson JR, Nori S, Kotter MRN, Druschel C, Curt A, Fehlings MG. Traumatic spinal cord injury. Nat Rev Dis Primers. 2017 Apr 27;3:17018. doi: 10.1038/nrdp.2017.18.

    PubMed 28447605

  • Yang R, Guo L, Wang P, Huang L, Tang Y, Wang W, Chen K, Ye J, Lu C, Wu Y, Shen H. Epidemiology of spinal cord injuries and risk factors for complete injuries in Guangdong, China: a retrospective study. PLoS One. 2014 Jan 28;9(1):e84733. doi: 10.1371/journal.pone.0084733. eCollection 2014.

    PubMed 24489652

  • Navarrete-Opazo A, Alcayaga J, Sepulveda O, Rojas E, Astudillo C. Repetitive Intermittent Hypoxia and Locomotor Training Enhances Walking Function in Incomplete Spinal Cord Injury Subjects: A Randomized, Triple-Blind, Placebo-Controlled Clinical Trial. J Neurotrauma. 2017 May 1;34(9):1803-1812. doi: 10.1089/neu.2016.4478. Epub 2016 Jul 19.

    PubMed 27329506

  • Champod AS, Eskes GA, Foster GE, Hanly PJ, Pialoux V, Beaudin AE, Poulin MJ. Effects of acute intermittent hypoxia on working memory in young healthy adults. Am J Respir Crit Care Med. 2013 May 15;187(10):1148-50. doi: 10.1164/rccm.201209-1742LE. No abstract available.

    PubMed 23675727

  • Manukhina EB, Downey HF, Shi X, Mallet RT. Intermittent hypoxia training protects cerebrovascular function in Alzheimer's disease. Exp Biol Med (Maywood). 2016 Jun;241(12):1351-63. doi: 10.1177/1535370216649060. Epub 2016 May 10.

    PubMed 27190276

  • Viscor G, Torrella JR, Corral L, Ricart A, Javierre C, Pages T, Ventura JL. Physiological and Biological Responses to Short-Term Intermittent Hypobaric Hypoxia Exposure: From Sports and Mountain Medicine to New Biomedical Applications. Front Physiol. 2018 Jul 9;9:814. doi: 10.3389/fphys.2018.00814. eCollection 2018.

    PubMed 30038574

  • Hayes HB, Jayaraman A, Herrmann M, Mitchell GS, Rymer WZ, Trumbower RD. Daily intermittent hypoxia enhances walking after chronic spinal cord injury: a randomized trial. Neurology. 2014 Jan 14;82(2):104-13. doi: 10.1212/01.WNL.0000437416.34298.43. Epub 2013 Nov 27.

    PubMed 24285617

  • Sandhu MS, Perez MA, Oudega M, Mitchell GS, Rymer WZ. Efficacy and time course of acute intermittent hypoxia effects in the upper extremities of people with cervical spinal cord injury. Exp Neurol. 2021 Aug;342:113722. doi: 10.1016/j.expneurol.2021.113722. Epub 2021 Apr 28.

    PubMed 33932397

  • Trumbower RD, Jayaraman A, Mitchell GS, Rymer WZ. Exposure to acute intermittent hypoxia augments somatic motor function in humans with incomplete spinal cord injury. Neurorehabil Neural Repair. 2012 Feb;26(2):163-72. doi: 10.1177/1545968311412055. Epub 2011 Aug 5.

    PubMed 21821826

Questions about this trial

What is this clinical trial studying?

A study testing Device induce acute intermittent hypoxia 9 % of Oxygen and Normoxia 21% of oxygen in people with Incomplete 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 6 inclusion and 5 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 22 May 2026. 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. Some participants in this study may receive a placebo. 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?

Upper limb function (time frame: change will be assessed on base line before intervention, post 7 days, post 14 days, post 21 days, post 30 days and a follow up week without intervention for retention effects). The study lists 8 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 NCT05491837, 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 22 May 2026.

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