- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab Province
-
Faisalābad, Punjab Province, Pakistan, 38000
- The university of Faisalabad
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A - Graded Motor Imagery
Graded motor imagery sessions were provided twice a week for six weeks.
Each GMI phase lasted for two 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.
|
|
Active Comparator: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
LANSS
Time Frame: Baseline, week 3 (mid-intervention), week 6 (post intervention)
|
Leeds Assessment of Neuropathic Symptoms and Sign
|
Baseline, week 3 (mid-intervention), week 6 (post intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Romberg Test
Time Frame: Baseline, week 6 (post-intervention)
|
Quantitative version of Romberg Test
|
Baseline, week 6 (post-intervention)
|
|
EORTC-QLQ-CIPN20
Time Frame: Baseline, week 6 (post-intervention)
|
European Organization of Research and Treatment of Cancer-Quality of Life Questionnaire-Chemotherapy Induced Peripheral Neuropathy 20
|
Baseline, week 6 (post-intervention)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TUF/IRB/98/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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