An interventional study of Sensorimotor Training Exercise and Conventional Exercise Therapy in Chemotherapy Induced Peripheral Neuropathy and Breast Cancer Patients, sponsored by Riphah International University. Recruiting at 2 sites in Pakistan. Open to female participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-12-17.
Sponsored by Riphah International University · Not applicable, Interventional, and Treatment
Chemotherapy-Induced Peripheral Neuropathy (CIPN) is a prevalent and clinically relevant side effect of chemotherapy in breast cancer patients. It occurs in 30-70% of cases. It can cause various sensory and motor symptoms. Specific exercise interventions have proven promising to target relevant symptoms. Therefore, the objective of this study is to determine the effects of Sensorimotor training on pain intensity, perceived balance confidence, and functional exercise capacity with chemotherapy-induced peripheral neuropathy in breast cancer patients.
The study incorporated a single blinded randomized controlled trial conducted at Mayo Hospital, Lahore. It involved 22 participants (N=22) recruited by using non-probability convenience sampling technique according to inclusion criteria and randomly allocated into either of two groups (Experimental group or Control group) using randomizer.org. The participants in experimental group performed sensorimotor training based on progressively challenging balance exercises on unstable surfaces. Participants performed three sets of exercises per session twice a week for 6 weeks, 45 minutes per session. The control group performed conventional exercises such as range of motion, stretching, strengthening, deep breathing and aerobic exercises for 2 times a week for 6 weeks, 45 minutes per session. Pre and post assessment of participants was done on numeric pain rating scale for pain intensity, TUG test for balance, activities-specific balance confidence scale for perceived balance confidence, 6-minute walk test for functional exercise capacity and EORTC QLQ C-30 for quality of life.
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Exclusion Criteria:
Participants will undergo sensorimotor training exercises targeting balance, pain reduction, and functional exercise capacity.
Behavioral: Sensorimotor Training Exercise
Participants will receive conventional exercise therapy as per standard guidelines.
Behavioral: Conventional Exercise Therapy
Participants will perform sensorimotor training exercises designed to improve balance, reduce pain intensity, and enhance functional exercise capacity. The program will include progressive exercises focusing on proprioception, neuromuscular coordination, and functional mobility. Sessions will be conducted thrice weekly over 12 weeks, supervised by a physiotherapist.
Participants will undergo conventional exercise therapy, including stretching, strengthening, and aerobic exercises, based on standard physiotherapy protocols. The therapy aims to maintain joint mobility, reduce stiffness, and improve general physical fitness. Sessions will be conducted thrice weekly over 12 weeks, supervised by a physiotherapist.
Numeric Pain Rating Scale (NPRS)
It is a uni-dimensional subjective measure of pain intensity in adults, including those with cancer pain. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible.
Time frame: 6 weeks
TUG Test
It is used to determine the fall risk and measure the progress of balance. Mobility and balance is assessed based on time to complete the test: \< 10 seconds = normal. \< 20 seconds = good mobility \< 30 seconds = walking and balance problems
Time frame: 6 weeks
Activities-Specific Balance Confidence Scale
The ABC-Scale is a self-reported assessment of the participant's level of confidence in static and dynamic balance while doing functional activities
Time frame: 6 weeks
6-Minute Walk Test
The 6-minute walk test (6MWT) is a standardized field test used to predict cardio-respiratory fitness in healthy individuals, as well as to assess functional exercise capacity and responsiveness to rehabilitation treatments in a variety of patient groups
Time frame: 6 weeks
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) Subscale
The FACT/GOG Ntx subscale is designed to measure chemotherapy-induced PN. It contains 11 items covering sensory neuropathy, motor neuropathy, hearing neuropathy, and dysfunction associated with neuropathy
Time frame: 6 weeks
EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30)
The EORTC QLQ-C30 is composed of nine multi-item scales: 5 functioning scales (physical, role, cognitive, emotional and social), a global QOL scale, and 3 symptom scales (fatigue, pain and nausea/vomiting).
Time frame: 6 weeks
Fullerton Advanced Balance Scale (FAB Scale)
It is a screening tool which can be used in different group. It has long form (consisting of 10 tasks) and a short form (consisting of 4 tasks). The scale consists of a 5-point Likert scale from 0-4.
Time frame: 6 weeks
Plan to share: No
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Riphah International University