To determine the effect of coordinative locomotor training on pain, balance and gait in chemotherapy induced peripheral neuropathy patients
Design
A randomized controlled trial with two parallel groups, a single blinded study of 3rd phase with 19 patients in each group which in total is 38
Settings and conduct
Allied Hospital Faisalabad, Madina teaching hospital Faisalabad. patientswill be kept unaware which group they are allocated to.
Participants/Inclusion and exclusion criteria
• Age 35 to 60 years
• Both genders male and female
• Willing to participate in research
• Cancer patients of stage Ⅰ-Ⅲ
• Receiving neurotoxic drugs (platinum based, taxanes based or both in combination)
• Have received at least 4 cycles of chemotherapy treatment
• Having numbness and tingling in distal areas
• Pain in distal areas
• At medium (19-24) to high (<19) risk of fall according to POMA
• Able to communicate in Punjabi/Urdu/English
• Cognitive dysfunction (Mini-Mental State exam score˂24)
• Any recent major surgery
• Unhealed lower extremity fracture
• Having diabetic neuropathy before getting chemotherapy drugs
• Other neurological problems including brain cancer
• Cardiovascular diseases
• Bone metastasis
• Lower limb lymphedema
• Musculoskeletal problems
• amputated limb
• with abnormal visual or auditory senses
• uncooperative patients
Intervention groups
Group A: coordinative locomotor training group. Group B: Conventional therapy group
Main outcome variables
1.pain 2.balance 3.gait
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240311061260N1
Registration date:2024-05-03, 1403/02/14
Registration timing:prospective
Last update:2024-05-03, 1403/02/14
Update count:0
Registration date
2024-05-03, 1403/02/14
Registrant information
Name
Aqsa Liaqat
Name of organization / entity
The University of Faisalabad
Country
Pakistan
Phone
+92 323 6002906
Email address
2022-ms-pt-047@tuf.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-06, 1403/02/17
Expected recruitment end date
2024-08-05, 1403/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of coordinative locomotor training on pain, balance and gait in chemotherapy induced peripheral neuropathy patients
Public title
Effectiveness of coordinative locomotor training on pain, balance and gait in chemotherapy induced peripheral neuropathy patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 35 to 60 years
Both genders male and female
Willing to participate in research
Cancer patients of stage Ⅰ-Ⅲ
Receiving neurotoxic drugs (platinum based, taxanes based or both in combination)
Have received at least 4 cycles of chemotherapy treatment
Having numbness and tingling in distal areas
Pain in distal areas
At medium (19-24) to high (<19) risk of fall according to POMA
Able to communicate in Punjabi/Urdu/English
Exclusion criteria:
Cognitive dysfunction (Mini-Mental State exam score˂24)
Any recent major surgery
Having diabetic neuropathy before getting chemotherapy drugs
Unhealed lower extremity fracture
Other neurological problems including brain cancer
Cardiovascular diseases
Bone metastasis
Lower limb lymphedema
Musculoskeletal problems
Amputated limb
With abnormal visual or auditory senses
Uncooperative patients
Age
From 35 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
Participants selected through purposive sampling will be randomly allocated through lottery method to either intrventional group or active control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participant in this study will be blinded as they will be randomly allocated through lottery method
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research and Ethics/Technical Committee for the University of Faisalabad
Street address
University Avenue, Faisal Town Canal Road
City
Faisalabad
Postal code
38000
Approval date
2024-02-17, 1402/11/28
Ethics committee reference number
TUF/DR/SA/MSPP/2024/408
Health conditions studied
1
Description of health condition studied
Chemotherapy induced peripheral neuropathy
ICD-10 code
G64
ICD-10 code description
Other disorders of peripheral nervous system
Primary outcomes
1
Description
Pain
Timepoint
Before treatment and at the end of 4 weeks of intervention
Method of measurement
Numerical pain rating scale(NPRS) was used
2
Description
Balance
Timepoint
Before the treatment and at the end of 4 weeks of intervention
Method of measurement
Performance oriented mobility assessment (POMA)
3
Description
Gait
Timepoint
Before the treatment and at the end of 4 weeks of intervention
Method of measurement
Timed up and go test(TUG), F8WT(figure of 8 walk test)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Coordinative Locomotor Training group
Category
Treatment - Other
2
Description
Control group: conventional training (Reaching out with hands crossed in sitting position, Sitting and getting up from chairs of various heights, Stepping forward, backward and sideways, Toe standing, Standing balanced and straight, Standing up from chair walk a certain distance and return to sit down, Climbing stairs)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Allied Hospital Faisalabad
Full name of responsible person
Anbreena Rasool
Street address
Dr. Tusi Raod
City
Faisalabad
Postal code
38000
Phone
+92 345 7936825
Email
assistant.professor.rehab.419@tuf.edu.pk
Web page address
https://ahfsd.pk/
2
Recruitment center
Name of recruitment center
Madinah Teaching Hospital
Full name of responsible person
Anbreena Rasool
Street address
Sargodha road university town
City
Faisalabad
Postal code
38000
Phone
+92 345 7936825
Email
assistant.professor.rehab.419@tuf.edu.pk
Web page address
https://mth.org.pk/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Anbreena Rasool
Street address
University Avenue, Faisal Town Canal road
City
Faisalabad
Postal code
38000
Phone
+92 345 7936825
Email
assistant.professor.rehab.419@tuf.edu.pk
Web page address
https://tuf.edu.pk/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Faisalabad
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Aqsa Liaqat
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
st.no.10 Mukhtar colony, Bhatta stop, Jhang road
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 335 7813723
Email
aqsa786liaqat@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Aqsa Liaqat
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
st. no. 10 Mukhtar colony, Bhatta stop, Jhang road
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 335 7813723
Email
aqsa786liaqat@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Aqsa Liaqat
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
st.no.10 Mukhtar colony, Bhatta stop, Jhang road
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 335 7813723
Email
aqsa786liaqat@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Effectiveness of Coordinative locomotor training on pain, balance and gait in chemotherapy induced peripheral neuropathy patients
When the data will become available and for how long
Starting 6 months after publication and it will remain available for everyone