Incomplete Spinal Cord Injury (SCI)AntigravityNCT07653529
Effect of Antigravity Treadmill Training on Cardiorespiratory Fitness and Lower Limb Function in Incomplete Spinal Cord Injury
A study testing Antigravity Treadmill for gait training and gait training and balance exercise in people with Incomplete Spinal Cord Injury (SCI), run by Middle East University.
Trial summary
This study aims to investigate the effect of locomotor training using an antigravity treadmill on cardiorespiratory fitness and lower limb function in patients with incomplete spinal cord injury. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Incomplete Spinal Cord Injury (SCI)
- What is being tested?
- Antigravity Treadmill for gait training and gait training and balance exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 12 Jun 2026to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Incomplete spinal cord injury (ASIA C or D)
- Injury duration more than 3 months
- Ability to stand with or without assistance
- Medically stable condition
Who cannot join
- Complete spinal cord injury
- Severe cardiopulmonary disorders
- Severe osteoporosis or fractures
- Severe cognitive impairment
- Other neurological disorders affecting gait
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Antigravity Treadmill Locomotor Training on Cardiorespiratory Fitness and Lower Limb Function in Patients With Incomplete Spinal Cord Injury
This study aims to investigate the effect of locomotor training using an antigravity treadmill on cardiorespiratory fitness and lower limb function in patients with incomplete spinal cord injury.
Read the detailed description
Sixty patients with incomplete spinal cord injury will be randomly assigned into two equal groups: the experimental group and the control group. Participants will be adults diagnosed with incomplete spinal cord injury classified as ASIA C or D. The experimental group will receive locomotor training using an antigravity treadmill in addition to conventional physiotherapy rehabilitation for 12 weeks. The control group will receive conventional physiotherapy rehabilitation only. The antigravity treadmill training program will be performed three sessions per week. Training intensity and body-weight support will be progressively adjusted according to patient tolerance and functional improvement.
Cardiorespiratory fitness will be evaluated using cardiopulmonary exercise testing and functional endurance assessments. Lower limb function will be assessed using gait and balance outcome measures.
- Conditions
- Incomplete Spinal Cord Injury (SCI)
- Being tested
- Antigravity Treadmill for gait training, gait training and balance exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antigravity Treadmill for gait trainingDevice
Antigravity treadmill for gait training
gait training and balance exerciseOther
gait training between Parallel bar Balance Exercise
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Active comparator | Antigravity Treadmill Training:
Participants will undergo locomotor training for 30-45 minutes per session, three sessions per week, for 12 weeks.
The training protocol will include:
* Warm-up for 5-10 minutes
* Walking training with partial body-weight support
* Progressive increase in treadmill speed according to tolerance
* Gradual reduction of body-weight support
* Cool-down period for 5 minutes Receives: Device: Antigravity Treadmill for gait training; Other: gait training and balance exercise |
| Control group | Active comparator | Thirty patients with incomplete spinal cord injury will receive gait training between parallel bar and balance exercise Receives: Other: gait training and balance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory fitness
Cardiopulmonary fitness will be measured by Cardiopulmonary Exercise Testing (CPET) to assess the integrated function of the cardiovascular, pulmonary, and muscular systems during exercise.
The gold-standard parameter obtained from CPET is:
VO₂max VO₂max: Maximum rate of oxygen consumption achieved during maximal exercise. Units: mL/kg/min
Measured: At base line and 12 weeks
Lower Limb Function
Lower limb function will be measured by 10-Meter Walk Test (10MWT) is a simple and reliable measure of walking speed,
Assesses:
Gait speed Procedure Mark a 10-meter walkway.
The patient will walks at:
Comfortable/self-selected speed (usual gait speed) Walking Speed (m/s)= Distance (m) /Time (s)
Measured: At base line and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start12 Jun 2026 (estimated)
- Primary completion12 Oct 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incomplete Spinal Cord Injury (SCI)Studies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Middle East University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Mohammed Youssef, Middle East University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07653529
- Sponsor's protocol ID
- Antigravity Treadmill SCI
- Acronym
- Antigravity
- Status last verified
- Jun 2026
- First submitted
- 20 May 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Antigravity Treadmill Locomotor Training on Cardiorespiratory Fitness and Lower Limb Function in Patients With Incomplete Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07653529
- Acronym / sponsor ID
- Antigravity / Antigravity Treadmill SCI
- Conditions
- Incomplete Spinal Cord Injury (SCI)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Middle East UniversityUniversity, hospital or other
- Study start
- 12 Jun 2026 (estimated)
- Primary completion
- 12 Oct 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 17 Jun 2026 (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.
This study aims to investigate the effect of locomotor training using an antigravity treadmill on cardiorespiratory fitness and lower limb function in patients with incomplete spinal cord injury.
Detailed description
Sixty patients with incomplete spinal cord injury will be randomly assigned into two equal groups: the experimental group and the control group. Participants will be adults diagnosed with incomplete spinal cord injury classified as ASIA C or D. The experimental group will receive locomotor training using an antigravity treadmill in addition to conventional physiotherapy rehabilitation for 12 weeks. The control group will receive conventional physiotherapy rehabilitation only. The antigravity treadmill training program will be performed three sessions per week. Training intensity and body-weight support will be progressively adjusted according to patient tolerance and functional improvement.
Cardiorespiratory fitness will be evaluated using cardiopulmonary exercise testing and functional endurance assessments. Lower limb function will be assessed using gait and balance outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Active comparator | Device: Antigravity Treadmill for gait training, Other: gait training and balance exerciseAntigravity Treadmill Training: Participants will undergo locomotor training for 30-45 minutes per session, three sessions per week, for 12 weeks. The training protocol will include: * Warm-up for 5-10 minutes * Walking training with partial body-weight support * Progressive increase in treadmill speed according to tolerance * Gradual reduction of body-weight support * Cool-down period for 5 minutes |
| Control group | Active comparator | Other: gait training and balance exerciseThirty patients with incomplete spinal cord injury will receive gait training between parallel bar and balance exercise |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Incomplete spinal cord injury (ASIA C or D)
- Injury duration more than 3 months
- Ability to stand with or without assistance
- Medically stable condition
Key exclusion criteria (5 listed)
- Complete spinal cord injury
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 |
|---|---|---|
| Antigravity Treadmill for gait trainingAntigravity treadmill for gait training | Device | Study Group |
| gait training and balance exercisegait training between Parallel bar Balance Exercise | Other | Control group, Study Group |
Primary outcome
Cardiorespiratory fitness
Time frame: At base line and 12 weeks
Cardiopulmonary fitness will be measured by Cardiopulmonary Exercise Testing (CPET) to assess the integrated function of the cardiovascular, pulmonary, and muscular systems during exercise. The gold-standard parameter obtained from CPET is: VO₂max VO₂max: Maximum rate of oxygen consumption achieved during maximal exercise. Units: mL/kg/min
Lower Limb Function
Time frame: At base line and 12 weeks
Lower limb function will be measured by 10-Meter Walk Test (10MWT) is a simple and reliable measure of walking speed, Assesses: Gait speed Procedure Mark a 10-meter walkway. The patient will walks at: Comfortable/self-selected speed (usual gait speed) Walking Speed (m/s)= Distance (m) /Time (s)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Antigravity Treadmill for gait training and gait training and balance exercise in people with Incomplete Spinal Cord Injury (SCI), run by Middle East University.
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 4 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: opening soon, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saher Lotfy Elgayar, phd (00962786757649, selgayar@meu.edu.jo), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory fitness (time frame: At base line and 12 weeks). The study lists 2 primary outcomes in all. 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 17 Jun 2026.