- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07648732
Contralateral Neurodynamic Mobilisation Improves Hamstring Flexibility.
A Randomized Controlled Crossover Trial of Contralateral Limb Neurodynamic Mobilisation on Hamstring Flexibility in Healthy Individuals.
The goal of this clinical trial is to investigate whether single limb neurodynamic mobilizations increase active knee extension (AKE) range of motion (ROM) of the contralateral limb. 20 healthy participants (10 females and 10 males, age; 20.8+1.7 years, height; 1.7+ 0.1m, weight; 76.7+ 15.4kg). AKE was measured pre- and post- intervention and control. The main question it aims to answer are:
It is hypothesized that contralateral neurodynamic mobilization will significantly increase AKE ROM in asymptomatic individuals.
Participants were allocated sequentially in an alternating order to study groups. This method aims to balance group sizes while simplifying the assignment. AKE was measured immediately before and after the allocated condition. One week later, at the same time of day, participants returned to complete the opposing condition following a standardized washout period to minimize carryover effects between conditions.
- Completed a neurodynamic mobilisation on the contralateral limb 6x30seconds, 10 second rest between sets.
- When acting as the control sat quietly for 4 minutes to match the duration of the intervention condition.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
This study investigates whether unilateral neurodynamic mobilisation produces measurable changes in active knee extension (AKE) range of motion (ROM) in the contralateral limb. Neurodynamic mobilisation techniques are commonly used to influence the mechanical and physiological behaviour of the peripheral nervous system, and previous research has demonstrated that neurodynamic "slider" techniques can acutely increase ipsilateral hamstring flexibility in asymptomatic individuals. However, the potential for contralateral effects, where treatment applied to one limb results in changes in the opposite limb, has not been directly evaluated using this specific mobilisation approach. The present study addresses this gap by examining whether a single session of unilateral neurodynamic mobilisation alters contralateral AKE performance.
The study was conducted using a counterbalanced crossover design consisting of two separate laboratory sessions: a neurodynamic mobilisation session and a control session. Each participant completed both sessions in a randomised order, with a one-week washout period implemented to minimise potential carry-over effects. All sessions were conducted at the same time of day to reduce variability related to diurnal fluctuations in neuromuscular performance.
During the neurodynamic mobilisation session, participants performed an active neurodynamic sliding technique adapted from previously published protocols. The technique was designed to promote excursion of the sciatic nerve without increasing tensile load. Participants were seated at the edge of a plinth in a flexed spinal posture with the hip and knee flexed and the ankle plantarflexed. From this position, they actively extended the cervical spine, extended the knee, and dorsiflexed the foot before returning to the starting position. Movements were paced using a metronome set at 60 beats per minute, with one full cycle of movement performed per beat. The mobilisation consisted of six sets of 30 seconds, separated by 10-second rest intervals, totalling 90 repetitions. The technique was applied only to the right lower limb.
The control session matched the duration of the mobilisation session but involved no movement. Participants remained seated quietly for four minutes following baseline measurement. This allowed comparison between the effects of the neurodynamic intervention and the passage of time alone.
AKE testing was performed immediately before and after each condition. The test was conducted with the participant lying supine, with the hip and knee of the test limb positioned at 90 degrees using a standardised support. Participants were instructed to actively extend the knee as far as possible while maintaining the hip position. Knee angle was measured using a bubble inclinometer placed on the anterior tibial border. Three measurements were taken at each time point, and the average value was used for analysis. All AKE measurements were performed on the contralateral (left) limb, as the mobilisation was applied to the right limb.
Statistical analysis involved a two-by-two repeated measures analysis of variance to examine the interaction between condition (mobilisation vs control) and time (pre vs post). Normality was assessed using the Shapiro-Wilk test. Post-hoc pairwise comparisons were conducted to explore the direction of significant interactions. Effect sizes were calculated using partial eta squared and Cohen's d. Test-retest reliability of the AKE test was assessed using data from the control condition collected one week apart, enabling calculation of the standard error of measurement (SEM) and minimal detectable change (MDC). These values were used to determine whether observed changes exceeded measurement error at both group and individual levels.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Healthy University students
- Aged 18-30
- participating in regular physical activity
- No current lower back pain
- No current illness
- No current hamstring injuries.
Exclusion Criteria:
- Participants aged 31 or over
- Did not partake in regular physical activity or
- Experienced lower back pain
- Currently suffering from an illness
- Currently sustained a hamstring injuries
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Neurodynamic Group
The neurodynamic technique was adapted from Castellote-Caballero12.
The active neurodynamic sliding technique required the participant to sit on the edge of the bed with their feet off the floor.
Participants sat in a slumped position with their thoracic and cervical spine flexed, knees flexed and feet plantar flexed.
They then extended their cervical spine, extended their knee and dorsiflexed their foot before returning to the starting position, counting as one repetition.
This was performed on the right leg for six sets of 30 seconds with a 10 second rest between sets, using a metronome app (ONYX 3, Apple, California) set at 60bpm.
Participants flexed and extended their leg on each metronome beat, completing 90 repetitions in total.
|
Sciatic Neurodynamic slider performed on the right leg.
|
|
Komparátor placeba: Control Group
Following an initial active knee extension test measurement, participants in the control condition were instructed to sit quietly for 4 minutes to match the duration of the intervention condition.
|
Sciatic Neurodynamic slider performed on the right leg.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Active Knee Extension Test
Časové okno: Baseline (Day 1) and Day 7.
|
Data will be recorded three times to then take a mean.
Active knee extension test will be performed utilising a bubble inclinometer placed on the participants tibial tuberosity.
Standardised hip flexion to 90 degrees as the active knee extension is performed.
|
Baseline (Day 1) and Day 7.
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Charlotte A Park, MSc, University of Salford
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- ethics number 1516-280
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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