- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07712302
Effect of GMI With and Without NM on LE in Cancer Patients With CIPN (CIPN)
Effect of Graded Motor Imagery With and Without Neural Mobilization on Lower Extremity in Cancer Patients With Chemotherapy-induced Peripheral Neuropathy
The goal of this interventional study is to learn if graded motor imagery with or without added neural mobilization can treat chemotherapy induced nerve related symptoms in lower limbs of cancer patients. The main questions it aims to answer are:
- Does graded motor imagery yields any added effects in relieving nerve related symptoms due to chemotherapy in lower limbs of cancer patients to the effects of nerve mobilization? Researchers will compare the effects of graded motor imagery as a standalone therapy (Group A) to the effects of graded motor imagery with nerve mobilization (Group B) Participants will take treatment sessions according to their allocated group, two sessions per week for six weeks.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Punjab Province
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Faisalābad, Punjab Province, Pakistan, 38000
- The university of Faisalabad
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Both male and female
- Age ranging from 31 to 65 years
- Diagnosed cancer patients (stage 1 to 3, cancer of any kind)
- Chemotherapy sessions (antineoplastic drugs) - at least 1 session
- Presence of glove and stocking peripheral neuropathy
- LANSS score greater than 12
- Agreed to give complete follow-up
Exclusion Criteria:
- Any co-morbid conditions that can cause peripheral neuropathy e.g. diabetes, chronic kidney failure
- Any trauma history that can cause peripheral neuropathic symptoms
- Pre-existing nerve entrapment syndromes
- Diagnosed stage 4 cancer patients
- Cancer patients taking palliative chemotherapy
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 |
|---|---|
|
Eksperimentel: Group A - Graded Motor Imagery
Graded motor imagery sessions were provided twice a week for six weeks.
Each GMI phase lasted for two weeks.
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Graded motor imagery is a series of three steps.
The first step, lateral recognition, includes graded left and right judgment exercises.
The second step involves imagining the performance of movements and the third, and last step involves performing movements in front of a mirror.
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Aktiv komparator: Group B - Grade Motor Imagey with Neural Mobilization
Graded motor imagery with neural mobilization sessions were provided twice a week for six weeks.
|
Graded motor imagery is a series of three steps.
The first step, lateral recognition, includes graded left and right judgment exercises.
The second step involves imagining the performance of movements and the third, and last step involves performing movements in front of a mirror.
Nerve mobilization allows movement between structures of nervous system and its surrounding areas.
It is used to mobilize the nervous system and maintain equilibrium inside the nervous system as well as in structures present in its surroundings.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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LANSS
Tidsramme: Baseline, week 3 (mid-intervention), week 6 (post intervention)
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Leeds Assessment of Neuropathic Symptoms and Sign
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Baseline, week 3 (mid-intervention), week 6 (post intervention)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Romberg Test
Tidsramme: Baseline, week 6 (post-intervention)
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Quantitative version of Romberg Test
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Baseline, week 6 (post-intervention)
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EORTC-QLQ-CIPN20
Tidsramme: Baseline, week 6 (post-intervention)
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European Organization of Research and Treatment of Cancer-Quality of Life Questionnaire-Chemotherapy Induced Peripheral Neuropathy 20
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Baseline, week 6 (post-intervention)
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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
- TUF/IRB/98/2025
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Kliniske forsøg med Graded Motor Imagery
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Istanbul University - CerrahpasaRekrutteringSund kontrol | Ankel ustabilitetTyrkiet (Türkiye)
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Marmara UniversityAfsluttetSmerte | SkulderimpingementsyndromKalkun
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Artvin Coruh UniversityMarmara UniversityAfsluttetKnæ slidgigt | Begrænsning, MobilitetKalkun
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IntegrumUniversity Medical Center Groningen; Sahlgrenska University Hospital, Sweden og andre samarbejdspartnereAfsluttetFantomsmerte i lemmerForenede Stater, Canada, Irland, Holland, Slovenien, Sverige, Tyskland
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Appalachian State UniversityAfsluttet
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Dokuz Eylul UniversityIzmir Katip Celebi UniversityUkendtTræning i motorisk billedsprog | Fysisk træning | Orofacial øvelseKalkun
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University of SalamancaRekruttering
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The Hong Kong Polytechnic UniversityIkke rekrutterer endnuDepression | Motoriske billeder | Rygmarvsskader (SCI) | Kognitive funktionerHong Kong
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Dokuz Eylul UniversityIkke rekrutterer endnuÆldre (Personer på 65 år eller derover)Kalkun
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Istanbul Medipol University HospitalRekruttering