Effects of Telerehabilitation Versus Clinical Rehabilitation on Chemotherapy Induced Peripheral Neuropathy
NCT ID: NCT06696976
Last Updated: 2024-11-20
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
66 participants
INTERVENTIONAL
2024-11-20
2025-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group A (telerehabilitation of neuropathic pain, physical function and quality of life)
Group A will receive Telerehabilitation of 60 minutes with short resting intervals .Treatment will be given 3 times per week for 12 weeks.
1. warm up of 5 minutes
2. Nerve gliding exercises of 10 minutes
3. Balance exercises of 20 minutes
4. Resistance training of 20 minutes
5. cold down of 5 minutes
Telerehabilitation
A qualified physiotherapist himself used the digital platform Zoom (Zoom Video Communications or WhatsApp video communication) to deliver synchronic online sessions (60 min each), sending each participant a link by email, half an hour before the weekly meetings. The patients were also invited to present themselves in comfortable gymnastic clothing and with tools useful for the motor program: a chair, a stick, a bottle full of water (or small weights if the patient had them), and a mat.
Nerve gliding exercises: These 5 Nerve gliding exercises will perform 3 times a week requiring 10 minutes to complete.
Balance exercises: Balance exercise include 10 exercises and take 20 minutes of completion, 2minute for each exercise.
Resistance training using Thera Band will performed with the presence of the researcher as an instructor.The main upper-extremity movements consisted of chest press, shoulder press etc and in lower extremity such as leg press ,back thgh press etc. in patient.
Group B (clinical rehabilitation of neuropathic pain, physical function and quality of life)
Group B will receive Clinical rehabilitation of 60 minutes with short resting intervals .Treatment will be given 3 times per week for 12 weeks.
1. warm up of 5 minutes
2. Nerve gliding exercises of 10 minutes
3. Balance exercises of 20 minutes
4. Resistance training of 20 minutes
5. cold down of 5 minutes
Clinical rehabilitation
A qualified physiotherapist himself used the digital platform Zoom (Zoom Video Communications or WhatsApp video communication) to deliver synchronic online sessions (60 min each), sending each participant a link by email, half an hour before the weekly meetings. The patients were also invited to present themselves in comfortable gymnastic clothing and with tools useful for the motor program: a chair, a stick, a bottle full of water (or small weights if the patient had them), and a mat.
Nerve gliding exercises: These 5 Nerve gliding exercises will perform 3 times a week requiring 10 minutes to complete.
Balance exercises: Balance exercise include 10 exercises and take 20 minutes of completion, 2minute for each exercise.
Resistance training using Thera Band will performed with the presence of the researcher as an instructor.The main upper-extremity movements consisted of chest press, shoulder press etc and in lower extremity such as leg press ,back thgh press etc. in patient.
Interventions
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Telerehabilitation
A qualified physiotherapist himself used the digital platform Zoom (Zoom Video Communications or WhatsApp video communication) to deliver synchronic online sessions (60 min each), sending each participant a link by email, half an hour before the weekly meetings. The patients were also invited to present themselves in comfortable gymnastic clothing and with tools useful for the motor program: a chair, a stick, a bottle full of water (or small weights if the patient had them), and a mat.
Nerve gliding exercises: These 5 Nerve gliding exercises will perform 3 times a week requiring 10 minutes to complete.
Balance exercises: Balance exercise include 10 exercises and take 20 minutes of completion, 2minute for each exercise.
Resistance training using Thera Band will performed with the presence of the researcher as an instructor.The main upper-extremity movements consisted of chest press, shoulder press etc and in lower extremity such as leg press ,back thgh press etc. in patient.
Clinical rehabilitation
A qualified physiotherapist himself used the digital platform Zoom (Zoom Video Communications or WhatsApp video communication) to deliver synchronic online sessions (60 min each), sending each participant a link by email, half an hour before the weekly meetings. The patients were also invited to present themselves in comfortable gymnastic clothing and with tools useful for the motor program: a chair, a stick, a bottle full of water (or small weights if the patient had them), and a mat.
Nerve gliding exercises: These 5 Nerve gliding exercises will perform 3 times a week requiring 10 minutes to complete.
Balance exercises: Balance exercise include 10 exercises and take 20 minutes of completion, 2minute for each exercise.
Resistance training using Thera Band will performed with the presence of the researcher as an instructor.The main upper-extremity movements consisted of chest press, shoulder press etc and in lower extremity such as leg press ,back thgh press etc. in patient.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
45 Years
75 Years
FEMALE
No
Sponsors
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Riphah International University
OTHER
Responsible Party
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Principal Investigators
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Muhammad Kashif, Phd
Role: STUDY_CHAIR
Riphah International University
Locations
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Riphah International University
Lahore, Punjab Province, Pakistan
Countries
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Central Contacts
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Facility Contacts
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References
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Postma TJ, Aaronson NK, Heimans JJ, Muller MJ, Hildebrand JG, Delattre JY, Hoang-Xuan K, Lanteri-Minet M, Grant R, Huddart R, Moynihan C, Maher J, Lucey R; EORTC Quality of Life Group. The development of an EORTC quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy: the QLQ-CIPN20. Eur J Cancer. 2005 May;41(8):1135-9. doi: 10.1016/j.ejca.2005.02.012. Epub 2005 Apr 14.
Cheville AL, Moynihan T, Herrin J, Loprinzi C, Kroenke K. Effect of Collaborative Telerehabilitation on Functional Impairment and Pain Among Patients With Advanced-Stage Cancer: A Randomized Clinical Trial. JAMA Oncol. 2019 May 1;5(5):644-652. doi: 10.1001/jamaoncol.2019.0011.
Loubani K, Schreuer N, Kizony R. Telerehabilitation for Managing Daily Participation among Breast Cancer Survivors during COVID-19: A Feasibility Study. J Clin Med. 2022 Feb 16;11(4):1022. doi: 10.3390/jcm11041022.
van Egmond MA, Engelbert RHH, Klinkenbijl JHG, van Berge Henegouwen MI, van der Schaaf M. Physiotherapy With Telerehabilitation in Patients With Complicated Postoperative Recovery After Esophageal Cancer Surgery: Feasibility Study. J Med Internet Res. 2020 Jun 9;22(6):e16056. doi: 10.2196/16056.
Galiano-Castillo N, Arroyo-Morales M, Lozano-Lozano M, Fernandez-Lao C, Martin-Martin L, Del-Moral-Avila R, Cantarero-Villanueva I. Effect of an Internet-based telehealth system on functional capacity and cognition in breast cancer survivors: a secondary analysis of a randomized controlled trial. Support Care Cancer. 2017 Nov;25(11):3551-3559. doi: 10.1007/s00520-017-3782-9. Epub 2017 Jun 22.
Cottrell MA, O'Leary SP, Swete-Kelly P, Elwell B, Hess S, Litchfield MA, McLoughlin I, Tweedy R, Raymer M, Hill AJ, Russell TG. Agreement between telehealth and in-person assessment of patients with chronic musculoskeletal conditions presenting to an advanced-practice physiotherapy screening clinic. Musculoskelet Sci Pract. 2018 Dec;38:99-105. doi: 10.1016/j.msksp.2018.09.014. Epub 2018 Oct 4.
Dhawan S, Andrews R, Kumar L, Wadhwa S, Shukla G. A Randomized Controlled Trial to Assess the Effectiveness of Muscle Strengthening and Balancing Exercises on Chemotherapy-Induced Peripheral Neuropathic Pain and Quality of Life Among Cancer Patients. Cancer Nurs. 2020 Jul/Aug;43(4):269-280. doi: 10.1097/NCC.0000000000000693.
Zhang YH, Hu HY, Xiong YC, Peng C, Hu L, Kong YZ, Wang YL, Guo JB, Bi S, Li TS, Ao LJ, Wang CH, Bai YL, Fang L, Ma C, Liao LR, Liu H, Zhu Y, Zhang ZJ, Liu CL, Fang GE, Wang XQ. Exercise for Neuropathic Pain: A Systematic Review and Expert Consensus. Front Med (Lausanne). 2021 Nov 24;8:756940. doi: 10.3389/fmed.2021.756940. eCollection 2021.
Zimmer P, Trebing S, Timmers-Trebing U, Schenk A, Paust R, Bloch W, Rudolph R, Streckmann F, Baumann FT. Eight-week, multimodal exercise counteracts a progress of chemotherapy-induced peripheral neuropathy and improves balance and strength in metastasized colorectal cancer patients: a randomized controlled trial. Support Care Cancer. 2018 Feb;26(2):615-624. doi: 10.1007/s00520-017-3875-5. Epub 2017 Sep 30.
Stubblefield MD, McNeely ML, Alfano CM, Mayer DK. A prospective surveillance model for physical rehabilitation of women with breast cancer: chemotherapy-induced peripheral neuropathy. Cancer. 2012 Apr 15;118(8 Suppl):2250-60. doi: 10.1002/cncr.27463.
Mols F, Beijers T, Vreugdenhil G, van de Poll-Franse L. Chemotherapy-induced peripheral neuropathy and its association with quality of life: a systematic review. Support Care Cancer. 2014 Aug;22(8):2261-9. doi: 10.1007/s00520-014-2255-7. Epub 2014 May 1.
Bahar-Ozdemir Y, Akyuz G, Kalkandelen M, Yumuk PF. The Effect of Therapeutic Exercises on Balance, Quality of Life, and Pain in Patients Who Were Receiving Neurotoxic Chemotherapy. Am J Phys Med Rehabil. 2020 Apr;99(4):291-299. doi: 10.1097/PHM.0000000000001324.
Other Identifiers
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REC/RCR&AHS/24/0229
Identifier Type: -
Identifier Source: org_study_id
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