The aim of this randomized control trial study is to determine the effects of the exercise program of Weight-bearing Exercise for Better Balance on static, dynamic and functional balance in people with diabetic polyneuropathy. Inclusion criteria are the diagnosis of diabetic polyneuropathy and the ability to perform the tests and exercises; exclusion criteria are the presence of any orthopaedic, neurological and cardiopulmonary problems which may interfere with exercise and test performance. 30 People diagnosed with diabetic polyneuropathy will be randomly assigned to intervention and control group. Participants in intervention group will perform the Weight-bearing Exercise for Better Balance program, containing 11 strengthening, balance, coordination and aerobic exercises. Participants in the control group will perform a battery of balance-strengthening exercises. All participants will perform the exercise programs for 8 weeks and will undergo balance assessment twice: once 24 hours before the beginning of the exercises and another time 24-48 hours after the last session of the exercise interventions. The primary outcome measures are displacement and velocity of postural sway, stability index and functional balance score.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014091619188N1
Registration date:2016-04-05, 1395/01/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-04-05, 1395/01/17
Registrant information
Name
Tabassom Ghanavati
Name of organization / entity
Ahvaz Jundishapur university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3332 0800
Email address
ghanavati-t@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2015-09-12, 1394/06/21
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of the Weight Bearing Exercise for a Better Balance program on static, dynamic and functional balance in people with diabetic neuropathy.
Public title
The effect of an exercise program on balance in people with diabetic neuropathy.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Diabetes mellitus diagnosed by physician; DPN diagnosis via clinical and laboratory assessments; Ability to participate in tests and exercises; Ability to perform aerobic activities for at least 30 mins without assistance
Exclusion:
Foot ulcer; Orthopedic or surgical impairments interfering with walking; Neurological consequences except diabetic polyneuropathy interfering with walking; Peripheral vascular disease; CNS involvement signs (dementia, Parkinson Disease, or Multiple Sclerosis); Musculoskeletal deformities at Lower Limb; Uncontrolled cardiopulmonary disease; History of dizziness, unstable angina, uncontrolled BP, tachycardia or resting arrhythmia; People who participated in balance training exercise, three months before starting study; Corrected visual acuity less than 20/70; MMSE score less than 24
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan BLVD. Ahvaz Jundishapur University of Medical Sciences Campus
City
Ahvaz
Postal code
Approval date
2015-10-16, 1394/07/24
Ethics committee reference number
IR.AJUMS.REC.1394.400
Health conditions studied
1
Description of health condition studied
Diabetic Polyneuropathy
ICD-10 code
G63.2*
ICD-10 code description
Diabetic polyneuropathy
Primary outcomes
1
Description
Sway Area
Timepoint
8 weeks
Method of measurement
force plate & instrumental wobble board
2
Description
Mean velocity of center of pressure
Timepoint
8 weeks
Method of measurement
force plate & instrumental wobble board
3
Description
Standard deviation of center of pressure velocity (Anteroposterior)
Timepoint
8 weeks
Method of measurement
force plate & instrumental wobble board
4
Description
Standard deviation of center of pressure velocity (Mediolateral)
Timepoint
8 weeks
Method of measurement
force plate & instrumental wobble board
5
Description
Functional balance score
Timepoint
8 weeks
Method of measurement
Berg balance scale
Secondary outcomes
1
Description
Depression
Timepoint
8 weeks
Method of measurement
GDS15 questionnaire
2
Description
Functional mobility
Timepoint
8 weeks
Method of measurement
Timed up and go test
Intervention groups
1
Description
Intervention Group:
WEBB Exercise:
1.High stepping on the spot
2. Standing with a decreased base
3. Graded reaching in standing
4. Stepping in different directions
5. Walking practice
6. Sit-to-stand
7. Heel raises
8. Lateral step-up
9. Forward step-up
10. Half- squats sliding down a wall
11. Bike, treadmill walk, overground walk or sit-to-stand
Category
Rehabilitation
2
Description
Control Group:
Balance-resisted exercise:
1. single leg standing
2. standing on toes and heels
3. tandem standing
4. Quadriceps strengthening
5. Lunge exercise
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Musculoskeletal Rehabilitation Research Center, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Ghanavati Tabassom
Street address
Golestan BLVD- Ahvaz University of Medical Sciences Campus- Rehabilitation Sciences Faculty- Musculoskeletal Rehabilitation Research Center
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
Full name of responsible person
Nader Saki
Street address
Goleastan BLVD. Ahvaz University of Medical Sciences Campus. The deputy of research development
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Musculoskeletal Rehabilitation Research Center, Ahvaz Jundishapur University of Medical Sciences, Ah
Full name of responsible person
Ghanavati Tabassom
Position
PhD of Physiotherapy
Other areas of specialty/work
Street address
Golestan BLVD- Ahvaz University of Medical Sciences Campus- Rehabilitation Sciences Faculty- Musculoskeletal Rehabilitation Research Center
City
Ahvaz
Postal code
6135715794
Phone
+98 61 3374 3102
Fax
Email
TBSM.GH@GMAIL.COM
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Musculoskeletal Rehabilitation Research Center, Ahvaz Jundishapur University of Medical Sciences, Ah
Full name of responsible person
Ghanavati Tabassom
Position
PhD of Physiotherapy
Other areas of specialty/work
Street address
Golestan BLVD- Ahvaz University of Medical Sciences Campus- Rehabilitation Sciences Faculty- Musculoskeletal Rehabilitation Research Center
City
Ahvaz
Postal code
6135715794
Phone
+98 61 3374 3102
Fax
Email
TBSM.GH@GMAIL.COM
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Musculoskeletal Rehabilitation Research Center, Ahvaz Jundishapur University of Medical Sciences, Ah
Full name of responsible person
Ghanavati Tabassom
Position
PhD of Physiotherapy
Other areas of specialty/work
Street address
Golestan BLVD- Ahvaz University of Medical Sciences Campus- Rehabilitation Sciences Faculty- Musculoskeletal Rehabilitation Research Center
City
Ahvaz
Postal code
6135715794
Phone
+98 61 3374 3102
Fax
Email
TBSM.GH@GMAIL.COM
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)