- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07762937
Neurodynamic Tensioning Plus Grip Strengthening for Hand Grip Strength
Effect of Neurodynamic Tensioning Added to a Grip Strengthening Program on Hand Grip Strength: A Randomized Controlled Trial
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
This study is designed as a prospective, two-arm, parallel-group randomized controlled trial investigating the additional effects of neurodynamic tensioning on hand grip strength in healthy adults. A total of 60 participants aged 18 to 40 years will be enrolled and randomly allocated in a 1:1 ratio to either a control group or an experimental group using computer-based block randomization.
Participants in both groups will perform a standardized grip strengthening program using an adjustable hand gripper for six weeks, three sessions per week. Each session will include three sets of 8-12 repetitions, with progressive resistance according to participant performance and perceived exertion.
In addition to the same grip strengthening program, participants in the experimental group will receive neurodynamic tensioning targeting the median and ulnar nerves. Neurodynamic techniques will be performed within pain-free limits using controlled tensioning movements. For each nerve, three sets of 10 repetitions will be performed before the grip strengthening exercises.
The primary outcome will be hand grip strength, measured using a Jamar hand dynamometer or an equivalent valid and reliable hand dynamometer. Grip strength will be assessed in standardized and different upper-extremity positions. Secondary outcomes will include pinch strength, manual dexterity, perceived exertion, intervention adherence, and adverse events.
Assessments will be performed at baseline (T0), week 3 (T1), and week 6 (T2). The outcome assessor will be blinded to group allocation. The main analysis will evaluate group, time, and group-by-time interaction effects to determine whether adding neurodynamic tensioning to grip strengthening results in greater improvement in hand grip strength than grip strengthening alone.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Uğur Sözlü, PhD
- Telefonní číslo: 05368921936
- E-mail: ugur.sozlu@gop.edu.tr
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Aged between 18 and 40 years.
- Willing to participate voluntarily in the study.
- No history of upper-extremity pain, injury, or surgery within the previous three months.
- No diagnosed neurological, rheumatological, or systemic disease affecting the peripheral nervous system.
- Sufficient cognitive ability to understand and follow the study protocol.
Exclusion Criteria:
- History of carpal tunnel syndrome, cervical radiculopathy, peripheral neuropathy, or upper-extremity entrapment neuropathy.
- History of upper-extremity fracture or surgery within the previous six months.
- Regular participation in grip strengthening exercises or intensive upper-extremity resistance training.
- Use of medication that may affect neuromuscular performance.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Aktivní komparátor: Grip Strengthening Group
Participants will perform a standardized grip strengthening program using an adjustable hand gripper for six weeks, three sessions per week.
Each session will consist of 3 sets of 8-12 repetitions.
Resistance will be progressively adjusted according to performance and perceived exertion.
No neurodynamic tensioning, neural gliding, or sham intervention will be applied to this group.
|
Participants will perform a standardized grip strengthening program using an adjustable hand gripper with the dominant hand for six weeks, three sessions per week.
Each session will consist of 3 sets of 8-12 repetitions, with approximately 2 seconds of gripping and 2 seconds of relaxation per repetition.
Rest periods of 60-90 seconds will be provided between sets.
Resistance will be progressively adjusted according to performance and perceived exertion.
|
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Experimentální: Neurodynamic Tensioning Plus Grip Strengthening Group
Participants will receive neurodynamic tensioning targeting the median and ulnar nerves in addition to the same standardized grip strengthening program.
For each nerve, neurodynamic tensioning will be performed as 3 sets of 10 repetitions using controlled rhythmic tensioning within pain-free limits.
The intervention will be performed for six weeks together with the grip strengthening program.
|
Participants will perform a standardized grip strengthening program using an adjustable hand gripper with the dominant hand for six weeks, three sessions per week.
Each session will consist of 3 sets of 8-12 repetitions, with approximately 2 seconds of gripping and 2 seconds of relaxation per repetition.
Rest periods of 60-90 seconds will be provided between sets.
Resistance will be progressively adjusted according to performance and perceived exertion.
Neurodynamic tensioning targeting the median and ulnar nerves will be applied before the grip strengthening program.
For each nerve, 3 sets of 10 repetitions will be performed, with each repetition consisting of approximately 4-5 seconds of controlled rhythmic tensioning.
A 30-second rest period will be provided between sets.
The technique will be performed within pain-free limits, producing only a mild stretching sensation.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Hand Grip Strength
Časové okno: Baseline, Week 3, and Week 6
|
Hand grip strength of the dominant hand will be measured in kilograms (kg) using a Jamar hand dynamometer or an equivalent valid and reliable hand dynamometer.
Measurements will be performed in three upper-extremity positions: standard seated position with the elbow at 90 degrees of flexion, elbow extension with the shoulder in a neutral position, and shoulder at 90 degrees of flexion with the elbow extended.
Three trials will be performed in each position, and the mean of the three measurements will be used for analysis.
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Baseline, Week 3, and Week 6
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Pinch Strength
Časové okno: Baseline, Week 3, and Week 6
|
Pinch strength will be assessed using a pinch gauge, if available, including lateral and/or palmar pinch measurements.
Measurements will be performed on the dominant hand, and changes over time will be compared between groups.
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Baseline, Week 3, and Week 6
|
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Change in Manual Dexterity
Časové okno: Baseline, Week 3, and Week 6
|
Manual dexterity will be assessed using the Nine-Hole Peg Test or an equivalent valid and reliable manual dexterity test.
Performance will be recorded at each assessment time point, and changes over time will be compared between groups.
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Baseline, Week 3, and Week 6
|
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Perceived Exertion During the Intervention
Časové okno: Baseline, Week 3, and Week 6
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Perceived exertion during the grip strengthening exercises will be recorded using a rating of perceived exertion (RPE).
RPE will be used to monitor exercise intensity and guide progression of resistance throughout the intervention.
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Baseline, Week 3, and Week 6
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Uğur Sözlü, PhD, Tokat Gaziosmanpaşa Üniversitesi
Publikace a užitečné odkazy
Obecné publikace
- Gamelas T, Fernandes A, Magalhaes I, Ferreira M, Machado S, Silva AG. Neural gliding versus neural tensioning: Effects on heat and cold thresholds, pain thresholds and hand grip strength in asymptomatic individuals. J Bodyw Mov Ther. 2019 Oct;23(4):799-804. doi: 10.1016/j.jbmt.2019.04.011. Epub 2019 Apr 24.
- Dierick F, Brismee JM, White O, Bouche AF, Perichon C, Filoni N, Barvaux V, Buisseret F. Fine adaptive precision grip control without maximum pinch strength changes after upper limb neurodynamic mobilization. Sci Rep. 2021 Jul 7;11(1):14009. doi: 10.1038/s41598-021-93036-8.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
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
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