- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04892576
Strength Training in Children With Cerebral Palsy
Stretch-shortening Cycle Exercises: an Efficient Training Model for Optimizing Gait-symmetry and Balance Capabilities in Children With Unilateral Cerebral Palsy
Studieoversigt
Detaljeret beskrivelse
Forty-two children with UCP were recruited from the Physical Therapy Outpatient Clinic of Collee of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, King Khalid Hospital, and a tertiary referral hospital, Al-Kharj, Saudi Arabia. Their age ranged between 8 and 12 years, were functioning at levels I or II according to the Gross Motor Function Classification System, and had spasticity level 1 or 1+ per the Modified Ashworth Scale. Children were excluded if they had fixed deformities, underwent neuromuscular or orthopedic surgery in the last 12 months, submitted to BOTOX injection in the past 6 months, attentional neglect, cardiopulmonary problems preventing them from performing high-intense exercise training.
Outcome measures
- Gait-symmetry Indices: Gait symmetry indices (Spatial and temporal) were measured through a 3D motion analysis system.
- Balance capabilities: several aspects of balance including sensory organization, reactive balance, and rhythmic weight shift were tested through a Pro Balance Master system.
The control and SSC groups received a standard rehabilitation program for 45 minutes, twice a week for eight consecutive weeks. The program comprised advanced balance training, and gait training exercises, postural and flexibility exercises, strength training exercises. Additionally, the SSC group received an SSC exercise program for 30 minutes, twice/week for eight weeks per the National Strength and Conditioning Association guidelines and American Academy of Pediatrics safety standards. The SSC program consisted of ten unilateral and bilateral lower limb plyometrics in the form of hopping/bounding/jumping activities. The SSC training was preceded by a warm-up for 5 minutes and ended up with a 5-min cooldown.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Riyadh
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Al Kharj, Riyadh, Saudi Arabien
- Ragab K. Elnaggar
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Unilateral cerebral palsy
- age from 8 to 12 years
- motor function level I or II according to the Gross Motor Function Classification System
- Spasticity level 1 or 1+ according to the Modified Ashworth Scale
Exclusion Criteria:
- Structural deformities
- Musculoskeletal or neural surgery in the last year
- BOTOX injection in the last 6 months.
- cardiopulmonary disorders interfering with the ability to engage in exercise training
- hemispatial neglect
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Control group
Participants in this group received the standard physical rehabilitation program.
|
The control group recieved the standard physical rehabilitation program conducted for 45 minutes, twice a week for eight consecutive weeks, and consisted of advanced balance training, gait training, postural and flexibility exercises, and strength training exercises. The SSC group received the same program in addition to the SSC exercises for 30 minutes, two times per week for eight successive weeks |
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Eksperimentel: SSC group
Participants in this group received the standard physical rehabilitation program as the control group in addition to the SSC exercise program
|
The control group recieved the standard physical rehabilitation program conducted for 45 minutes, twice a week for eight consecutive weeks, and consisted of advanced balance training, gait training, postural and flexibility exercises, and strength training exercises. The SSC group received the same program in addition to the SSC exercises for 30 minutes, two times per week for eight successive weeks |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Gait symmetry
Tidsramme: 2 months
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Gait symmetry indices (spatial and temporal) were measured about the step length and single-limb support time of the paretic and non-paretic leg through a 3D motion analysis system
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2 months
|
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Balance Capabilities
Tidsramme: 2 months
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Some aspects of balance capabilities including sensory organization, reactive balance, and rhythmic weight shift were measured through a Pro Balance Master sytem.
|
2 months
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RHPT/0018/0078
Plan for individuelle deltagerdata (IPD)
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