- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Saher Lotfy Elgayar, phd
- Telefonnummer: 00962786757649
- E-post: selgayar@meu.edu.jo
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske 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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- Antigravity Treadmill SCI
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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