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Effect of Biofeedback-Enhanced Exergaming, Exergaming Alone, and Traditional Physical Therapy on Motor Function, Adherence, and Engagement in Children With Cerebral Palsy: A RCT

A legfontosabb adatok

Ki végzi
Ziauddin University
Hol
Pakisztán1 helyszín, 1 országbanVálassz országot a helyszínekhez
Azonosító
Állapot
Toborzás még nem indult
Résztvevők
90 fő, tervezett
Kezdés
2025. dec. 15.
Tervezett befejezés
2026. aug. 1.
A vizsgálat típusa
Beavatkozással járó, 3 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
A vizsgált kezelések
  • exergaming
  • biofeedback-enhanced exergaming
  • Traditional Physical Therapy
A regiszteradat frissítve
2026. január 8.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for children aged 6 to 12 with cerebral palsy who can walk and use their hands fairly well. It compares video-game exercise, with or without live body feedback, to usual physical therapy.

Életkor
6 to 12 years
Nem
Boys and girls
A betegség stádiuma
Cerebral palsy of the spastic diplegia, spastic hemiplegia or mild ataxia type. Gross Motor Function Classification System (GMFCS) Level I or II, and Manual Ability Classification System (MACS) Level I or II. The child must be able to stand and do basic movements with no help or minimal help.
Biomarker vagy leletérték
A score at or above the 25th percentile (T-score ≥ 40) on the NIH Toolbox Picture Sequence Memory Test (PSMT), a memory test. The child must be able to follow simple two-step commands.

A részvétel fő kizáró okai

  • GMFCS Level III or higher, or MACS Level III or higher
  • Severe uncorrected vision or hearing problems that would get in the way of playing the games
  • Uncontrolled epilepsy or another nerve condition that rules out active movement
  • Serious behaviour or attention problems that prevent taking part in game tasks
  • Taking part in another treatment trial that may interfere

A regiszter feltételei, szó szerint

Mind a 10 feltétel megnézéseKevesebb

Ki vehet részt

  • Diagnosed with Cerebral Palsy (CP), specifically spastic diplegia, spastic hemiplegia, or mild ataxia
  • Gross Motor Function Classification System (GMFCS) Level I or II
  • Male and female aged between 6 and 12 years at the time of enrollment
  • Manual Ability Classification System (MACS) Level I or II
  • Able to follow simple two-step commands, with or without augmentative and alternative communication (AAC)
  • Demonstrates adequate cognitive functioning based on the NIH Toolbox Picture Sequence Memory Test (PSMT), scoring at or above the 25th percentile (T-score ≥ 40) based on age-adjusted norms
  • Hearing and vision adequate to participate in exergaming tasks (with or without assistive devices)
  • Able to stand and participate in basic movements with or without minimal assistance
  • Willingness to participate and written informed consent from parent/guardian with assent from the child

Ki nem vehet részt

  • GMFCS Level III or higher, indicating significant gross motor limitations; MACS Level III or higher, indicating significant manual impairment; Severe uncorrected visual or hearing impairment that would interfere with interaction during exergaming; Uncontrolled epilepsy or other neurological condition contraindicating active movement; Significant behavioral or attention challenges that prevent engagement with game-based tasks; Score below the 25th percentile on the PSMT, indicating insufficient episodic memory to follow game tasks; Involvement in any other intervention trial that may interfere with study participation; Medical conditions that contraindicate participation in physical activity (as determined by a physician)

Nézd meg, megfelelhetsz-e

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

  • 6 és 12 év között vagy?

Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.

Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.

A vizsgálatról

Mit akar kideríteni a vizsgálat

Cerebral Palsy (CP) accounts for approximately 0.9% of the global disease burden and affects 2.4-4% of children under 5 years old, with associated developmental and coordination impairments. Pediatric physical therapy aims to enhance independence and quality of life; however, maintaining adherence to conventional treatment remains a major challenge due to its repetitive and monotonous nature, leading to reduced motivation and limited functional progress.

A teljes eredeti leírásKevesebb

Exergaming, integrating physical activity with interactive video games, has emerged as an engaging alternative shown to improve motor function, balance, and coordination in children with motor impairments. While existing evidence supports its effectiveness, few randomized studies have explored the addition of real-time physiological biofeedback (e.g., surface EMG with motion tracking) within exergaming platforms. Evidence on adherence and engagement outcomes also remains limited.

This trial addresses that gap by investigating the combined effects of biofeedback-enhanced exergaming versus exergaming alone and traditional physiotherapy in children with CP (GMFCS levels I-II). Incorporating real-time biofeedback provides immediate physiological feedback, potentially enhancing motor learning, motivation, and adherence, key components for improving long-term rehabilitation outcomes in pediatric populations.

A vizsgálat 3 csoportja

  • exergamingA vizsgált kezelés

    The exergaming program will use Kinect Adventures (River Rush, Reflex Ridge) to train balance, agility, and trunk control; Kinect Sports to improve lower-limb activation, hand-eye coordination, and bilateral movements; Just Dance Kids for rhythmic stepping; and Kinect Party/Happy Action Theater to encourage free movement. Optional MIRA Rehab modules may target posture and agility. Sessions will be held three times per week for twelve weeks, starting with a light warm-up, followed by 20-30 minutes of targeted exergames, and ending with a cool-down. Game difficulty will progressively increase, and therapists will track progress through scores and completion times.

  • biofeedback-enhanced exergamingA vizsgált kezelés

    This group will perform the same exergaming activities as the exergaming group, with the added integration of real-time multimodal biofeedback to enhance motor learning. The frequency and duration of sessions will be identical to the exergaming group. Participants will receive on-screen visual guides that indicate whether their movements are being performed correctly, along with auditory feedback through performance-linked cues such as pitch changes or sound alerts prompting postural adjustments. Optional vibration alerts from wearable devices may also be used to correct improper posture. The biofeedback system will incorporate surface EMG (Delsys Trigno) to assess bilateral muscle activity during gameplay, and motion tracking through the Microsoft Kinect SDK (v2 or Azure) to capture and analyze joint movements, posture, and detailed ranges of motion.

  • traditional physical therapyMár használt kezelés, összehasonlításként

    Children in this group will receive standard physical therapy to improve gross motor function, especially balance and mobility. Sessions will be held three times per week for twelve weeks, lasting 30-45 minutes. The protocol includes a 5-minute warm-up, 12-15 minutes of strengthening for hip, knee, and ankle muscles, 8-10 minutes of balance training using wobble boards or foam, and 8-10 minutes of functional mobility tasks such as sit-to-stand and stair practice, followed by a 2-5 minute cool-down. Therapists will follow standardized instructions, and treatment fidelity will be monitored through checklists, with 10% of sessions audited monthly.

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
Effect of Biofeedback-Enhanced Exergaming, Exergaming Alone, and Traditional Physical Therapy on Motor Function, Adherence, and Engagement in Children With Cerebral Palsy (GMFCS I-II): A Randomized Controlled Trial
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 14.
Illeszkedési kérdések
Forrás: NCT07325981: ki vehet részt
A regiszteradat frissítve
2026. január 8.