Clinical trial NCT06696976: Effects of Telerehabilitation Versus Clinical Rehabilitation on Chemotherapy Induced Peripheral Neuropathy
Official title: Effects of Telerehabilitation Versus Clinical Rehabilitation on Neuropathic Pain, Physical Function and Quality of Life in Chemotherapy Induced Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chemotherapy Induced Peripheral Neuropathy
Keywords: Chemotherapy induced peripheral neuropathy
Telerehabilitation
Quality of life
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 66
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine the comparative effects of telerehabilitation versus clinical rehabilitation on neuropathic pain, physical function and quality of life in Chemotherapy induced peripheral neuropathy patients.

Detailed description: Chemotherapy-induced peripheral neuropathy (CIPN) is among the most prevalent and debilitating adverse effects of cancer treatment. CIPN increase risk of falls and impair physical function and quality of life (QOL). Physical therapy improves the CIPN symptoms, quality of life and physical function in cancer patients after chemotherapy. Telerehabilitation technologies such as telephone and video conferencing, have the capability of bringing services into the survivors' home and manage the symptoms without needing to have direct physical contact with the hospital or clinic services. The aim of this study is to determine the comparative effects of telerehabilitation versus clinical rehabilitation on neuropathic pain, physical function and quality of life.

This study will be a randomized clinical trial that will conducted at Gujranwala institute of Nuclear Medicine hospital in which sixty-six cancer patient who will sustain grade 3 and grade 4 of European Organization for Research and Treatment of Cancer Quality of life-Chemotherapy Induced Peripheral Neuropathy Questionnaire (EORTC-QLQ-CIPN20)will randomly allocated to Group A(n=33)who will receive Telerehabilitation and Group B (n=33) who will receive clinical rehabilitation using the computer generated method. The sample size calculated for this trial will be 66. Interventions will be given in both groups for 60 minutes for 12 weeks (3times per week).10 minutes for Nerve Gliding exercises ,20 minutes for Balance training and 20 minutes forResistance training (using Therapeutic band).European Organization for Research and Treatment of Cancer Quality of Life-Chemotherapy Induced Peripheral Neuropathy Questionnaire (EORTC QLQ-CIPN20) will be used to assess quality of life. Berg balance scale for balance and Manual Muscle testing for muscle strength. The data will be entered and analyzed using SPSS 26. Statistical significance will be set at p=0.05. Normality of data will be assessed through Kolmogorov-Smirnov test. Assessment will be carried out at baseline,6th week, 12th week after discontinuation of treatment and 18th week follow up. For between group analysis of parametric data Independent T test will be used, while Mann Whitney test will be applied for non-parametric data. For within group comparison repeated measure ANOVA will be used, for non-parametric data, Friedman ANOVA will be applied.

Eligibility criteria: Inclusion Criteria:

* Female patients with breast cancer.
* Patients of age between 45 to 75years.
* Patient expected to survive for 6 month or more.
* Patient after specific chemotherapy such as taxanes(paclitaxel),vinca alkaloids(vinorelbine),bortezomib, lenalidomide and platinum-based.
* Patient with Stage 1 to 3.
* Patients have prior history of mechanical nerve entrapment without clinical symptoms (carpal tunnel syndrome) were included.
* Patient who sustained grade 3 and 4 of European Organization for Research and Treatment of Cancer Quality of Life-Chemotherapy-Induced Peripheral Neuropathy Questionnaire (EORTC QLQ-CIPN20).

Exclusion Criteria:

* Patients with history of peripheral neuropathy.
* Participants are excluded if they had comorbid conditions causing peripheral neuropathic symptoms (including previous chemotherapy or diabetes or alcohol abuse and non-alcoholic liver diseases.
* Patients not scheduled for one of the aforementioned taxane-based regimens.
* Patients with vitamin D or B12 deficiency.
* Non-ambulatory Patients.
* Patients reluctant to practice exercise program.
* Patient have impaired visual or vestibular system and presence of bone or any kind of central nervous system involvement , including cancer.

Primary outcomes:
measure: NUMERIC PAIN RATING SCALE
timeFrame: 12th week
measure: EORTC CIPN20
timeFrame: 12th week
measure: The Berg balance scale (BBS):
timeFrame: 12th week
measure: Manual Muscle testing (MMT)
timeFrame: 12th week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Kashif, Phd
role: STUDY_CHAIR
References:
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