Ignite Creation Date:
2024-05-06 @ 5:57 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05491837
Status:
RECRUITING
Last Update Posted:
2022-12-20
First Post:
2022-07-24
Brief Title:
Effects of Intermittent Hypoxia in Upper and Lower Limb Functions in Persons With Incomplete Spinal Cord Injury
Sponsor:
Riphah International University
Organization:
Riphah International University
Study Overview
Official Title:
Effects of Device Induced Acute Intermittent Hypoxia in Upper and Lower Limb Activity Functions in Persons With Incomplete Spinal Cord Injury
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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
Detailed Description:
Study design and setting This will be Randomized Controlled Trail triple blind study design The study will be conducted in Paraplegic center Peshawar PCP Pakistan httpsparaplegiccenterorg
Blinding of the participants Patients selection and their allocation of treatments to experimental and control will be done by team of physiotherapists working in paraplegic center Peshawar whose will not the part of investigation team Treatment will be given by trained physiotherapist within paraplegic center Peshawar while data will be analyzed by statistician working in Riphah international University Islamabad Pakistan The investigators patients and the treatment providers will be anonymous from the group allocation treatment they receive and data analysis
Sampling Technique Since the sample frame is available so sample technique will be Random Sampling by computer generated table of random number
Sample size Sample size for the study calculated via G Power sample size calculator with power of 95 and α error probability is 005 on the following assumption
Walking speed 10MWT post intervention in groups are IH 17158 vs Nx7128s the effect was determined as 209 So the total sample size for both groups is 8 4 Since this sample size is less so we consider our effect size 09 thus total sample size will be 68 each grip will be having 34 participants
Participants Person with incomplete spinal cord injury will be our study participants
ToolsOutcome measures include the following
1 Hypoxico Hyp 123
2 Hand Dynamometer Grip strength Hydraulic guage pinch strength
3 Upper limb functional Test 9-Hole and Pegs Test Box and Block Test
4 Quick-DASH Disability of arm shoulder and hand
5 Ten Minute Walk Test Time up and Go Test walking performance
6 Six Minute Walk Testendurance
7 Berg Balance Test Balance
8 WHO-QOL BREF Urdu version
9 Brain derived neurotrophic factors BDNF
10 Level of Hemoglobin RBS and Hematocrits Interventions details After randomly allocation of the patients into intervention and SHAM group The 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 The 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 Both these protocols will be provided 3 timesweek for a period of 4 weeks Both groups will continue their routine rehabilitation for the upper and lower limb exerccises within the center Post assessments for the said variable will be carried out each week post 7 days post 14 days post 21 days post 30 days and a follow up week for retention effects
Data collection Procedure After informed consent all the willing and eligible participants will be randomly divided into intervention and SHAM group Participants demographic details will be taken which includes participants age geographic location socioeconomic status history of onset of iSCI level of spinal cord injury ASIA classification CD and BMI Outcome measure will be assessed as baseline at each week and after final as retention effect ass discussed above
Ethical consideration Ethical consideration has been provided by the ethical board of Riphah International University Islamabad RIPHAHRCRSRECLetter-0129 dated march 2022
Blinding of the participants Patients selection and their allocation of treatments to experimental and control will be done by team of physiotherapists working in paraplegic center Peshawar whose will not the part of investigation team Treatment will be given by trained physiotherapist within paraplegic center Peshawar while data will be analyzed by statistician working in Riphah international University Islamabad Pakistan The investigators patients and the treatment providers will be anonymous from the group allocation treatment they receive and data analysis
Sampling Technique Since the sample frame is available so sample technique will be Random Sampling by computer generated table of random number
Sample size Sample size for the study calculated via G Power sample size calculator with power of 95 and α error probability is 005 on the following assumption
Walking speed 10MWT post intervention in groups are IH 17158 vs Nx7128s the effect was determined as 209 So the total sample size for both groups is 8 4 Since this sample size is less so we consider our effect size 09 thus total sample size will be 68 each grip will be having 34 participants
Participants Person with incomplete spinal cord injury will be our study participants
ToolsOutcome measures include the following
1 Hypoxico Hyp 123
2 Hand Dynamometer Grip strength Hydraulic guage pinch strength
3 Upper limb functional Test 9-Hole and Pegs Test Box and Block Test
4 Quick-DASH Disability of arm shoulder and hand
5 Ten Minute Walk Test Time up and Go Test walking performance
6 Six Minute Walk Testendurance
7 Berg Balance Test Balance
8 WHO-QOL BREF Urdu version
9 Brain derived neurotrophic factors BDNF
10 Level of Hemoglobin RBS and Hematocrits Interventions details After randomly allocation of the patients into intervention and SHAM group The 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 The 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 Both these protocols will be provided 3 timesweek for a period of 4 weeks Both groups will continue their routine rehabilitation for the upper and lower limb exerccises within the center Post assessments for the said variable will be carried out each week post 7 days post 14 days post 21 days post 30 days and a follow up week for retention effects
Data collection Procedure After informed consent all the willing and eligible participants will be randomly divided into intervention and SHAM group Participants demographic details will be taken which includes participants age geographic location socioeconomic status history of onset of iSCI level of spinal cord injury ASIA classification CD and BMI Outcome measure will be assessed as baseline at each week and after final as retention effect ass discussed above
Ethical consideration Ethical consideration has been provided by the ethical board of Riphah International University Islamabad RIPHAHRCRSRECLetter-0129 dated march 2022
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None