- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07653529
Effect of Antigravity Treadmill Training on Cardiorespiratory Fitness and Lower Limb Function in Incomplete Spinal Cord Injury (Antigravity)
Effect of Antigravity Treadmill Locomotor Training on Cardiorespiratory Fitness and Lower Limb Function in Patients With Incomplete Spinal Cord Injury
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Saher Lotfy Elgayar, phd
- Telefonnummer: 00962786757649
- E-mail: selgayar@meu.edu.jo
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
Incomplete spinal cord injury (ASIA C or D)
- Injury duration more than 3 months
- Ability to stand with or without assistance
- Medically stable condition
Exclusion Criteria:
Complete spinal cord injury
- Severe cardiopulmonary disorders
- Severe osteoporosis or fractures
- Severe cognitive impairment
- Other neurological disorders affecting gait
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Study Group
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:
|
Antigravity treadmill for gait training
gait training between Parallel bar Balance Exercise
|
|
Aktiv komparator: Control group
Thirty patients with incomplete spinal cord injury will receive gait training between parallel bar and balance exercise
|
gait training between Parallel bar Balance Exercise
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Cardiorespiratory fitness
Tidsramme: 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 |
At base line and 12 weeks
|
|
Lower Limb Function
Tidsramme: 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) |
At base line and 12 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- Antigravity Treadmill SCI
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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