To determine the effect of Wii-fit-based balance training combined
with planter cutaneous sensory stimulation for balance control in older
adults with diabetic neuropathy.
To determine the effect of Wii-Fit based balance training alone in older
adults with diabetic neuropathy
To compare the effect of Wii-fit-based balance training combined with
planter cutaneous sensory stimulation with Wii-fit-based balance training
alone for balance control in older adults with diabetic neuropathy
Design
Randomized controlled trial
Settings and conduct
The Diabetes Center. Single blinded
Participants/Inclusion and exclusion criteria
Inclusion criteria: Older adults age limit between 60-90 years. Diagnosed Diabetes Mellitus for more than 1 year having neuropathy. Both genders. ( Male and Female).
Exclusion Criteria: Dependence on others to complete activities of daily living.Loss of protective foot sensations.Comorbidities including visual impairment, cerebrovascular accident,
Orthopaedic trauma, Labyrinthitis, peripheral vascular disease, Heart failure. Using the assistive device for ambulation.
Intervention groups
The interventional group
underwent conventional balance training for (20mins), Wii-fit Balance training (20mins)
along with cutaneous sensory stimulations (10mins) which were given by using flannel
cloth and brittle brush twice a week for the first four consecutive weeks.
Main outcome variables
Balance
General information
Reason for update
Acronym
Balance management in diabetic neuropathy patients (BMDN)
IRCT registration information
IRCT registration number:IRCT20210615051585N3
Registration date:2022-01-11, 1400/10/21
Registration timing:retrospective
Last update:2022-01-11, 1400/10/21
Update count:0
Registration date
2022-01-11, 1400/10/21
Registrant information
Name
Saima Gul
Name of organization / entity
Shifa Tameer - e - Millat University
Country
Pakistan
Phone
+92 51 8441751
Email address
saimagul.ahs@stmu.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-12, 1400/01/23
Expected recruitment end date
2021-07-15, 1400/04/24
Actual recruitment start date
2021-04-12, 1400/01/23
Actual recruitment end date
2021-07-15, 1400/04/24
Trial completion date
2021-07-15, 1400/04/24
Scientific title
Effect of Wii-fit based balance training combined with planter cutaneous sensory stimulation in older adults with diabetic neuropathy
Public title
Effect of Wii-fit based balance training combined with planter cutaneous sensory stimulation in older adults with diabetic neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Older adults age limit between 60-90 years
Diagnosed Diabetes Mellitus for more than 1 year having neuropathy
Both genders. ( Male and Female)
Exclusion criteria:
Dependence on others to complete activities of daily living
Loss of protective foot sensations
Comorbidities including visual impairment, cerebrovascular accident, Orthopaedic trauma, Labyrinthitis, peripheral vascular disease, Heart failure
Using the assistive device for ambulation
Age
From 60 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
22
Actual sample size reached:
21
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment for treatment using sealed envelope 26 Sheets of properly cut Aluminum paper double the size of the paper. 26 Sheets of Carbon paper cut into appropriate size according to the paper used. A standard-sized square paper was taken in which group "(Wiifit)" was marked. In this way, 11 papers were prepared marked with "(Wii-fit)" and 11 square-shaped papers marked with "(Wii-fit+SS)". The sheet of paper on which either (Wii-fit) or (Wii-fit + SS) was marked was folded to fit the envelope. A sheet of Carbon paper was placed on the top of the folded paper (marked either (Wii-fit) or (Wii-fit + SS)) facing the envelope. Then the sheet of Aluminum foil was wrapped on the carbon paper (with folded paper inside). All the above prepared were placed in the envelope (which was completely opaque), the envelope was then sealed. In this way 11 envelops of "(Wii-fit)" and 11 envelops of "(Wii-fit)" were prepared. With a total number of 22 envelopes. These 22 envelopes were then thoroughly shuffled like a deck of cards. The envelopes were then marked with numbers 1-22. Each participant picked the envelope in order from 1-22 and was given an intervention (Wii-fit or Wii-fit) accordingly.
Blinding (investigator's opinion)
Single blinded
Blinding description
Only the researcher doing the study knows which treatment or intervention the participant is receiving. It makes results less likely to be biased.
Placebo
Not used
Assignment
Parallel
Other design features
N/A
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Review Board and Ethics Committee (IRB and EC) Shifa International Hospital.
Street address
Department of Rehabilitation Sciences, Dar ul Shifa Campus, Shifa Tameer e Millat University
City
Islamabad
Postal code
25000
Approval date
2021-06-18, 1400/03/28
Ethics committee reference number
IRB#187-21
Health conditions studied
1
Description of health condition studied
Diabetic Neuropathy
ICD-10 code
E11.40
ICD-10 code description
Type 2 diabetes mellites with diabetic neuropathy
Primary outcomes
1
Description
Balance
Timepoint
Baseline, after intervention.
Method of measurement
Berg Balance Scale
Secondary outcomes
1
Description
To determine balance
Timepoint
8th week
Method of measurement
secondary outcome was measured by time up and go.
Intervention groups
1
Description
Wii-fit Group: Treatment for 20 min 2 sessions per week for 8 weeks along with the conventional therapy. Conventional therapy includes: passive stretching, repetitive task-specific activities, passive, active-assisted and active ROM exercises. The Wii-fit protocol included using Wii-fit set and the games. The game uses a unique platform peripheral called the Wii Balance Board, on which the player stands during exercise. The Board is not a rocking balance board but a device that tracks the user's center of balance. The patient played each game for 10-mins per session.
Category
Rehabilitation
2
Description
Wii-fit+SS Group: The same treatment (as above) given to the participants along with Cutaneous sensory stimulations (10mins) which was given by using flannel cloth and brittle brush
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
The Diabetes Center
Full name of responsible person
Dr. Tayyiba Zulqarnain
Street address
Murree Expressway, near Toll Plaza, Islamabad Punjab
City
Islamabad
Postal code
44000
Phone
+92 51 4481100
Fax
+92 51 4481100
Email
tayyabazulqarnain@gmail.com
Web page address
https://www.tdc.com.pk/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shifa Tameer e Millat University
Full name of responsible person
Dr. Saima Gul
Street address
Department of Rehabilitation Sciences, Dar ul Shifa Campus, Shifa Tameer e Millat University
City
Islamabad
Postal code
25000
Phone
+92 51 8441751
Fax
+92 51 8441751
Email
saimagul.ahs@stmu.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shifa Tameer e Millat University
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Shifa Tameer e Millat University
Full name of responsible person
Dr. Saima Gul
Position
Assosiate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Department of Rehabilitation Sciences, Dar ul Shifa Campus, Shifa Tameer e Millat University
City
Islamabad
Province
Islamabad
Postal code
25000
Phone
+92 332 1964158
Email
Saimaa.gul@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shifa Tameer e Millat University
Full name of responsible person
Dr. Saima Gul
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Department of Rehabilitation Sciences, Dar ul Shifa Campus, Shifa Tameer e Millat University
City
Islamabad
Province
Federal
Postal code
25000
Phone
+92 332 1964158
Email
saimaa.gul@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shifa Tameer e Millat University
Full name of responsible person
Dr. Saima Gul
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Department of Rehabilitation Sciences, Dar ul Shifa Campus, Shifa Tameer e Millat University
City
Islamabad
Province
Federal
Postal code
25000
Phone
+92 332 1964158
Email
saimagul.ahs@stmu.edu.pk
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD