Spinal Cord InjuriesNCT03262766
Daily Intermittent Hypoxia and Task-Specific Upper Limb Training in Persons With Chronic Incomplete SCI
A study testing Acute Intermittent Hypoxia (AIH) and Upper extremity training in people with Spinal Cord Injuries, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
The purpose of this research study is to investigate the effectiveness of a combinatorial therapy of breathing low oxygen in short bursts-acute intermittent hypoxia (AIH) and upper limb training on arm strength and function, and comparing it with individual treatments in persons with spinal cord injuries. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Acute Intermittent Hypoxia (AIH) and Upper extremity training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2017to 30 Oct 2020
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Motor incomplete SCI at or below C2 and above T2 with non-progressive etiology
- Age between 18 to 70 years
- More than 1 year since SCI
- Ability to close and open one's hand without assistance.
- Ability to understand and the willingness to sign a written informed consent.
Who cannot join
- Presence of any of the following medical conditions: congestive heart failure, arrhythmia, uncontrolled high blood pressure, uncontrolled diabetes mellitus, COPD/emphysema and severe asthma.
- Weight over 250 pounds.
- Persons with known coronary artery disease, a history of myocardial infarction and known carotid or intracerebral artery stenosis.
- A medical clearance will be required if patients are taking any other investigational agents.
- Women who are pregnant or nursing will be excluded, as the potential effects of intermittent hypoxia on pregnant women and fetus are unknown.
- Individuals with tracheostomy will be excluded.
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- Subjects cannot pursue other research studies which may interfere with our treatment.
- Subjects with diagnosed obstructive sleep apnea will be excluded as that may affect the response or sensitivity to AIH,
- Orthopedic injuries or recent surgeries affecting the mobility of upper extremity and shoulder
- We will not include the following populations:
- Adults unable to consent, unless accompanied by a legally authorized representative.
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Shirley Ryan AbilityLab
Chicago, Illinois, 60610
Milap Sandhu, PT, PhD, 312-238-6529, m-sandhu@northwestern.edu
About this study
The purpose of this research study is to investigate the effectiveness of a combinatorial therapy of breathing low oxygen in short bursts-acute intermittent hypoxia (AIH) and upper limb training on arm strength and function, and comparing it with individual treatments in persons with spinal cord injuries.
The investigators hypothesize that a combinatorial intervention with AIH therapy + upper limb training will be significantly more effective in improving hand function, compared to individual treatments alone.
To test this hypothesis, the investigators will determine the impact of combined daily AIH therapy and high-repetition task-specific upper extremity training on arm strength and hand dexterity in persons with spinal cord injuries.
Read the detailed description
The objective of this research project is to determine the effect of a 5-day intervention with daily acute intermittent hypoxia (AIH) therapy, either alone or coupled with task-specific training, on upper extremity function in individuals with chronic, incomplete SCI.
Previous work already determined that breathing low levels of oxygen for short periods of time (also known as acute intermittent hypoxia) can improve lower limb motor function in persons with spinal injury. Specifically, this study is being done to determine if pre-treatment with intermittent hypoxia can enhance the beneficial effects of upper limb training on the restoration of limb function in persons with spinal injury.
This is a blinded study, which means that the subject will not know which treatment they are receiving. They will either receive intermittent periods of low oxygen (hypoxia) or a session composed of only normal room air. They will be randomly assigned to a treatment based on chance. Neither the subject nor the researcher chooses the assigned group. They will have an equal chance of being in either group.
The participant will receive a daily 5-day intervention with either acute intermittent hypoxia (AIH) therapy or room air, either alone or coupled with task-specific training, on upper extremity function in individuals with chronic, incomplete SCI. This will be preceded by a baseline testing visit prior to the intervention, and followed by a 4 week follow up period to assess the effects of the interventions over time.
The total duration of participation in the study intervention protocol is 1 week. Including the follow up period, the subjects will participate for a total of 6 weeks.
- Conditions
- Spinal Cord Injuries
- Being tested
- Acute Intermittent Hypoxia (AIH), Upper extremity training, Sham Acute intermittent hypoxia
- Keywords
- Acute Intermittent Hypoxia, Upper Extremity Training
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute Intermittent Hypoxia (AIH)Other
This will consist of up to 90 seconds of 9-10% O2 (FiO2 0.09), alternating with up to 90 seconds of 21% O2 (normoxic air FiO2 0.21). The delivery of hypoxia and normoxic air mixtures will be repeated up to 18 times per session each, for a total of up to 45 minutes.
Upper extremity trainingBehavioural
Subjects will receive 45 minutes of task-specific, high repetition upper extremity training, given using an upper-limb robotic rehabilitation device, the Armeo Spring®. Armeo Spring is a gravity support system based on an ergonomic arm exoskeleton with integrated springs. It cradles the entire arm, from shoulder to the hand, and counterbalances the weight of the user's arm. Therefore, it enhances any residual function and neuromuscular control, and assists in active movement across a large 3-D workspace. The Armeo software contains an extensive library of game-like movement exercises supported by a virtual-reality training environment that displays the functional task along with immediate performance feedback.
Sham Acute intermittent hypoxiaOther
This will consist of up to 90 seconds of 21% O2 (FiO2 0.21), alternating with up to 90 seconds of 21% O2 (normoxic air FiO2 0.21). The delivery of alternating normoxic air will be repeated up to 18 times per session each, for a total of up to 45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Acute intermittent hypoxia (AIH) | Active comparator | Subjects will be exposed to acute intermittent hypoxia, daily for 5 days. Each session will consist of up to 90 seconds of 9-10% Oxygen (FiO2 0.09), alternating with up to 90 seconds of 21% Oxygen (normoxic air FiO2 0.21). The delivery of hypoxia and normoxic air mixtures will be repeated up to 18 times per session each, for up to 45 minutes, to maintain SpO2 at 80-90%. If the SpO2 drops below 75%, hypoxia exposure will be terminated immediately.
There is continuous monitoring of respiratory rate, heart rate and peripheral arterial oxyhemoglobin saturation (SpO2). Receives: Other: Acute Intermittent Hypoxia (AIH) |
| AIH+ Upper extremity training | Experimental | Subjects will be exposed to acute intermittent hypoxia, daily for 5 days. Each session will consist of up to 90 seconds of 9-10% Oxygen (FiO2 0.09), alternating with up to 90 seconds of 21% Oxygen (normoxic air FiO2 0.21). The delivery of hypoxia and normoxic air mixtures will be repeated up to 18 times per session each, for up to 45 minutes, to maintain SpO2 at 80-90%. If the SpO2 drops below 75%, hypoxia exposure will be terminated immediately.
There is continuous monitoring of respiratory rate, heart rate and peripheral arterial oxyhemoglobin saturation (SpO2).
Following the AIH protocol, subjects will receive 45 minutes of task-specific, high repetition upper extremity training, given using an upper-limb robotic rehabilitation device, the Armeo Spring®. Receives: Other: Acute Intermittent Hypoxia (AIH); Behavioral: Upper extremity training |
| Sham AIH + Upper extremity training | Active comparator | Subjects will be exposed to sham hypoxia daily for 5 days. Each session will consist of up to 90 seconds of 21% Oxygen (FiO2 0.21), alternating with up to 90 seconds of 21% Oxygen (normoxic air FiO2 0.21). The delivery will be repeated up to 18 times per session each, for a total of up to 45 minutes.
There is continuous monitoring of respiratory rate, heart rate and peripheral arterial oxyhemoglobin saturation (SpO2).
Following the sham AIH protocol, subjects will receive 45 minutes of task-specific, high repetition upper extremity training. Upper extremity training will be given using an upper-limb robotic rehabilitation device, the Armeo Spring®. Receives: Behavioral: Upper extremity training; Other: Sham Acute intermittent hypoxia |
| Sham Acute intermittent hypoxia | Sham comparator | Subjects will be exposed to sham hypoxia daily for 5 days. Each session will consist of up to 90 seconds of 21% Oxygen (FiO2 0.21), alternating with up to 90 seconds of 21% Oxygen (normoxic air FiO2 0.21). The delivery will be repeated up to 18 times per session each, for a total of up to 45 minutes.
There is continuous monitoring of respiratory rate, heart rate and peripheral arterial oxyhemoglobin saturation (SpO2). Receives: Other: Sham Acute intermittent hypoxia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grip strength (Hydraulic Handheld Dynamometer)
A dynamometer measures maximum gross grasp (kg) averaged over attempt with each hand. The minimum possible value of zero kg will be assigned when the participant cannot actively flex the fingers or grasp the dynamometer
Measured: 10-12 minutes
Secondary outcomes (9)
Pinch grip (Strength gauge Dynamometry)
A pinch gauge measures maximum pinch force (kg) averaged over attempt with each hand. The minimum possible value of zero kg will be assigned when the participant cannot actively squeeze the pinch meter between thumb and index finger.
Measured: 10-12 minutes
Box and Block Test (BBT)
Measure of manual dexterity that requires repeatedly moving 1-inch blocks from one side of a box to another in 60 seconds.
Measured: 5 min, with time to instruct
Nine Hole Peg Test
A test of upper extremity dexterity which involves picking up pegs from a container and placing them, one by one, into holes on a board, as quickly as possible. Participants must then remove the pegs, one by one, and replace them into the original container. The total time in seconds is recorded.
Measured: Upto 10-12 minutes, dependent on their ability to complete the test.
Spinal Cord Independence Measure (SCIM III)
An outcome measure that is specifically designed to evaluate functional ability in individuals with spinal cord injury. It has established reliability, internal consistency, and construct validity (when compared to the Functional Independence Measure, and the Walking Index for Spinal Cord Injury). It consists of 19 items in 3 separate domains, including self-care, respiration and sphincter management, and mobility.
Measured: 10-15 minutes
Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)
This is a clinical impairment measure used to evaluate sensory and motor hand function in individuals with cervical spinal cord injuries. It is composed of different domains, including: strength, sensation (dorsal and palmar), prehension ability, and prehension performance.
Measured: 45-60 minutes
Capabilities of Upper Extremity Questionnaire
This is a structured interview that serves to evaluate functional limitations in individuals with tetraplegia. Participants are provided with questions regarding the difficulty of a given task as it relates to using their more-affected and less-affected sides. This outcome measure has established minimal detectable change and standard error of measure values. It also has demonstrated excellent criterion validity.
Measured: 10 minutes
California Verbal Learning Test
The California Verbal Learning Test (CVLT) is a neuropsychological test which can be used to assess an individual's verbal memory abilities.
Measured: 45 minutes
Delis-Kaplan Executive Function System (D-KEFS™)
Neurophysological test that assesses key components of executive functions within verbal and spatial modalities.
Measured: 10-12 minutes
N-back test
The n -back task is a continuous performance task that is commonly used as an assessment in cognitive neuroscience to measure a part of working memory and working memory capacity.
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start24 Jun 2017
- Primary completion30 Oct 2020 (estimated)
- Study completion30 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Factorial
- Model description
- Subjects will then be randomized to one of the four arms. The four arms of interventions are: 1. Acute intermittent hypoxia (AIH) therapy 2. AIH therapy + Upper extremity training 3. Sham AIH therapy + Upper extremity training 4. Sham Hypoxia
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Department of Education
- Responsible party
- Principal investigator, Milap Sandhu, Shirley Ryan AbilityLab
- Investigators
- William Z Rymer, MD, PhD, Study director, Shirley Ryan AbilityLabMilap Sandhu, PT, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03262766
- Sponsor's protocol ID
- STU00204305
- Other IDs
- 81428, 81349
- Status last verified
- Feb 2020
- First submitted
- 23 Aug 2017
- Last updated
- 19 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Intermittent Hypoxia and Task-Specific Upper Limb Training in Persons With Chronic Incomplete SCI
- ClinicalTrials.gov ID
- NCT03262766
- Acronym / sponsor ID
- STU00204305
- Conditions
- Spinal Cord Injuries
- Keywords
- Acute Intermittent Hypoxia, Upper Extremity Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- U.S. Department of Education
- Study start
- 24 Jun 2017 (actual)
- Primary completion
- 30 Oct 2020 (estimated)
- Study completion
- 30 Oct 2020 (estimated)
- First posted
- 25 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to investigate the effectiveness of a combinatorial therapy of breathing low oxygen in short bursts-acute intermittent hypoxia (AIH) and upper limb training on arm strength and function, and comparing it with individual treatments in persons with spinal cord injuries.
The investigators hypothesize that a combinatorial intervention with AIH therapy + upper limb training will be significantly more effective in improving hand function, compared to individual treatments alone.
To test this hypothesis, the investigators will determine the impact of combined daily AIH therapy and high-repetition task-specific upper extremity training on arm strength and hand dexterity in persons with spinal cord injuries.
Detailed description
The objective of this research project is to determine the effect of a 5-day intervention with daily acute intermittent hypoxia (AIH) therapy, either alone or coupled with task-specific training, on upper extremity function in individuals with chronic, incomplete SCI.
Previous work already determined that breathing low levels of oxygen for short periods of time (also known as acute intermittent hypoxia) can improve lower limb motor function in persons with spinal injury. Specifically, this study is being done to determine if pre-treatment with intermittent hypoxia can enhance the beneficial effects of upper limb training on the restoration of limb function in persons with spinal injury.
This is a blinded study, which means that the subject will not know which treatment they are receiving. They will either receive intermittent periods of low oxygen (hypoxia) or a session composed of only normal room air. They will be randomly assigned to a treatment based on chance. Neither the subject nor the researcher chooses the assigned group. They will have an equal chance of being in either group.
The participant will receive a daily 5-day intervention with either acute intermittent hypoxia (AIH) therapy or room air, either alone or coupled with task-specific training, on upper extremity function in individuals with chronic, incomplete SCI. This will be preceded by a baseline testing visit prior to the intervention, and followed by a 4 week follow up period to assess the effects of the interventions over time.
The total duration of participation in the study intervention protocol is 1 week. Including the follow up period, the subjects will participate for a total of 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Subjects will then be randomized to one of the four arms. The four arms of interventions are: 1. Acute intermittent hypoxia (AIH) therapy 2. AIH therapy + Upper extremity training 3. Sham AIH therapy + Upper extremity training 4. Sham Hypoxia
| Arm | Type | Receives |
|---|---|---|
| Acute intermittent hypoxia (AIH) | Active comparator | Other: Acute Intermittent Hypoxia (AIH)Subjects will be exposed to acute intermittent hypoxia, daily for 5 days. Each session will consist of up to 90 seconds of 9-10% Oxygen (FiO2 0.09), alternating with up to 90 seconds of 21% Oxygen (normoxic air FiO2 0.21). The delivery of hypoxia and normoxic air mixtures will be repeated up to 18 times per session each, for up to 45 minutes, to maintain SpO2 at 80-90%. If the SpO2 drops below 75%, hypoxia exposure will be terminated immediately. There is continuous monitoring of respiratory rate, heart rate and peripheral arterial oxyhemoglobin saturation (SpO2). |
| AIH+ Upper extremity training | Experimental | Other: Acute Intermittent Hypoxia (AIH), Behavioral: Upper extremity trainingSubjects will be exposed to acute intermittent hypoxia, daily for 5 days. Each session will consist of up to 90 seconds of 9-10% Oxygen (FiO2 0.09), alternating with up to 90 seconds of 21% Oxygen (normoxic air FiO2 0.21). The delivery of hypoxia and normoxic air mixtures will be repeated up to 18 times per session each, for up to 45 minutes, to maintain SpO2 at 80-90%. If the SpO2 drops below 75%, hypoxia exposure will be terminated immediately. There is continuous monitoring of respiratory rate, heart rate and peripheral arterial oxyhemoglobin saturation (SpO2). Following the AIH protocol, subjects will receive 45 minutes of task-specific, high repetition upper extremity training, given using an upper-limb robotic rehabilitation device, the Armeo Spring®. |
| Sham AIH + Upper extremity training | Active comparator | Behavioral: Upper extremity training, Other: Sham Acute intermittent hypoxiaSubjects will be exposed to sham hypoxia daily for 5 days. Each session will consist of up to 90 seconds of 21% Oxygen (FiO2 0.21), alternating with up to 90 seconds of 21% Oxygen (normoxic air FiO2 0.21). The delivery will be repeated up to 18 times per session each, for a total of up to 45 minutes. There is continuous monitoring of respiratory rate, heart rate and peripheral arterial oxyhemoglobin saturation (SpO2). Following the sham AIH protocol, subjects will receive 45 minutes of task-specific, high repetition upper extremity training. Upper extremity training will be given using an upper-limb robotic rehabilitation device, the Armeo Spring®. |
| Sham Acute intermittent hypoxia | Sham comparator | Other: Sham Acute intermittent hypoxiaSubjects will be exposed to sham hypoxia daily for 5 days. Each session will consist of up to 90 seconds of 21% Oxygen (FiO2 0.21), alternating with up to 90 seconds of 21% Oxygen (normoxic air FiO2 0.21). The delivery will be repeated up to 18 times per session each, for a total of up to 45 minutes. There is continuous monitoring of respiratory rate, heart rate and peripheral arterial oxyhemoglobin saturation (SpO2). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Motor incomplete SCI at or below C2 and above T2 with non-progressive etiology
- Age between 18 to 70 years
- More than 1 year since SCI
- Ability to close and open one's hand without assistance.
- Ability to understand and the willingness to sign a written informed consent.
Key exclusion criteria (14 listed)
- Presence of any of the following medical conditions: congestive heart failure, arrhythmia, uncontrolled high blood pressure, uncontrolled diabetes mellitus, COPD/emphysema and severe asthma.
- Weight over 250 pounds.
- Persons with known coronary artery disease, a history of myocardial infarction and known carotid or intracerebral artery stenosis.
- A medical clearance will be required if patients are taking any other investigational agents.
- Women who are pregnant or nursing will be excluded, as the potential effects of intermittent hypoxia on pregnant women and fetus are unknown.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute Intermittent Hypoxia (AIH)This will consist of up to 90 seconds of 9-10% O2 (FiO2 0.09), alternating with up to 90 seconds of 21% O2 (normoxic air FiO2 0.21). The delivery of hypoxia and normoxic air mixtures will be repeated up to 18 times per session each, for a total of up to 45 minutes. | Other | AIH+ Upper extremity training, Acute intermittent hypoxia (AIH) |
| Upper extremity trainingSubjects will receive 45 minutes of task-specific, high repetition upper extremity training, given using an upper-limb robotic rehabilitation device, the Armeo Spring®. Armeo Spring is a gravity support system based on an ergonomic arm exoskeleton with integrated springs. It cradles the entire arm, from shoulder to the hand, and counterbalances the weight of the user's arm. Therefore, it enhances any residual function and neuromuscular control, and assists in active movement across a large 3-D workspace. The Armeo software contains an extensive library of game-like movement exercises supported by a virtual-reality training environment that displays the functional task along with immediate performance feedback. | Behavioural | AIH+ Upper extremity training, Sham AIH + Upper extremity training |
| Sham Acute intermittent hypoxiaThis will consist of up to 90 seconds of 21% O2 (FiO2 0.21), alternating with up to 90 seconds of 21% O2 (normoxic air FiO2 0.21). The delivery of alternating normoxic air will be repeated up to 18 times per session each, for a total of up to 45 minutes. | Other | Sham AIH + Upper extremity training, Sham Acute intermittent hypoxia |
Primary outcome
Grip strength (Hydraulic Handheld Dynamometer)
Time frame: 10-12 minutes
A dynamometer measures maximum gross grasp (kg) averaged over attempt with each hand. The minimum possible value of zero kg will be assigned when the participant cannot actively flex the fingers or grasp the dynamometer
9 secondary outcomes
Pinch grip (Strength gauge Dynamometry)
Time frame: 10-12 minutes
Box and Block Test (BBT)
Time frame: 5 min, with time to instruct
Nine Hole Peg Test
Time frame: Upto 10-12 minutes, dependent on their ability to complete the test.
Spinal Cord Independence Measure (SCIM III)
Time frame: 10-15 minutes
Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)
Time frame: 45-60 minutes
Capabilities of Upper Extremity Questionnaire
Time frame: 10 minutes
California Verbal Learning Test
Time frame: 45 minutes
Delis-Kaplan Executive Function System (D-KEFS™)
Time frame: 10-12 minutes
N-back test
Time frame: 45 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Z Rymer, MD, PhD study director
Shirley Ryan AbilityLab
Milap Sandhu, PT, PhD principal investigator
Shirley Ryan AbilityLab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute Intermittent Hypoxia (AIH) and Upper extremity training in people with Spinal Cord Injuries, run by Shirley Ryan AbilityLab at 1 site in United States.
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 14 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: status not confirmed, as of the sponsor's last update on 19 Feb 2020. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Milap Sandhu, PT, PhD (312-238-6529, m-sandhu@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grip strength (Hydraulic Handheld Dynamometer) (time frame: 10-12 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Feb 2020.