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

Riphah International University

Status: Completed

Conditions: Incomplete Spinal Cord Injury

Treatments: Other: Normoxia 21% of oxygen; Other: Device induce acute intermittent hypoxia 9 % of Oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT05491837

RIPHAH/RCRS/REC/Letter-0129

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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68 participants in 2 patient groups

Interventional group

Experimental group

Description:

The 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.

Treatment:

Other: Device induce acute intermittent hypoxia 9 % of Oxygen

Other: Normoxia 21% of oxygen

Control group

Sham Comparator group

Description:

SHAM 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.

Treatment:

Other: Normoxia 21% of oxygen