PNF and Gait Training on Balance and Gait in Diabetic Neueopathy Patients
Primary Purpose
Diabetic Neuropathies
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Pnf exercises
Gait training exercises
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Neuropathies focused on measuring PNF, DGI, BBS, TAT, MNSI
Eligibility Criteria
Inclusion criteria:
Both male and female in the age group 40-65 • Patients suffering from Diabetes Mellitus (Type 1, Type 2), suffering From effects of diabetic neuropathy such as Gait instability, imbalance, numbness, tingling, Paresthesia in lower limbs for a duration of at least three months.
- HbA1c more than 7 from 6 months.
- Score higher than 7 out of 15 in the Michigan Neuropathy questionnaire scale and Examination score higher than 2.5.
Exclusion Criteria:
Patients suffering from significant CNS dysfunctions.
- Musculoskeletal deformities
- Vestibular dysfunction
- Internal ear infections
- Complete sensory loss
Sites / Locations
- Central Park Teaching Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Pnf exercises
Gait training exercises
Arm Description
warm up, rhythmic stabilization, hold relax, contract relax and light exercises performed on three muscle groups
exercises comprised of one foot balancing, leg raises, heel raises, tight-rope walking.
Outcomes
Primary Outcome Measures
tinnete scale
The test requires a hard armless chair, a stopwatch and also, a 15 feet even and uniform walkway. It has 2 sections: one assesses balance abilities in a chair and also in standing; the other assesses dynamic balance during gait on a 15 feet even walkway.Next, the patient will have to walk a few meters at a normal speed, followed by turning and walking back at a "fast but safe" speed. The patient will then sit back down. As well as in the first part of the test, there are some points the evaluator has to look at. These are the length and height of the steps, the symmetry and continuity of the steps and straightness of the trunk.
During this test, the patient can use any assistive devices (walking stick, crutches, zimmer frame) they would normally use
Berg Balance Scale
Document each task and/or give instructions as written. When scoring, please record the lowest response category that applies for each item.
In most items, the subject is asked to maintain a given position for a specific time. Progressively more points are deducted if:
the time or distance requirements are not met the subject's performance warrants supervision the subject touches an external support or receives assistance from the examiner The subject should understand that they must maintain their balance while attempting the tasks. The choices of which leg to stand on or how far to reach are left to the subject. Poor judgment will adversely influence the performance and the scoring.
Equipment required for testing is a stopwatch or watch with a second hand, and a ruler or other indicator of 2, 5, and 10 inches. Chairs used during testing should be a reasonable height. Either a step or a stool of average step height may be used for item.
Dynamic Gait index
8 functional walking tests are performed by the subject and marked out of three according to the lowest category which applies. 24 is the total individual score possible. Scores of 19 or less have been related to increase incidence of falls.
Equipment needed
Box (Shoebox), Cones (2), Stairs, 20' walkway, 15" wide
Completion Time
15 minutes
Secondary Outcome Measures
Full Information
NCT ID
NCT05593133
First Posted
October 21, 2022
Last Updated
October 21, 2022
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05593133
Brief Title
PNF and Gait Training on Balance and Gait in Diabetic Neueopathy Patients
Official Title
Comparative Effects of PNF and Gait Training Exercises on Balance and Gait in Patients With Diabetic Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 5, 2021 (Actual)
Primary Completion Date
September 8, 2021 (Actual)
Study Completion Date
January 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine the effects of PNF and Gait Training Exercises on Balance and Gait in diabetic neuropathy patients . 40 patients will be explained in detail about the study procedure. Informed consent will be taken. Patients will be divided in two groups each consisting of 20 people.
Subjects will be evaluated using the Michigan Neuropathy Screening Questionnaire (screening tool) . One group will be tested by PNF techniques and the second group will be tested by Gait Training exercises.
Balance will be assessed by Berg Balance scale (BBS) and Tinetti scale before, during and after the study to assess risk of fall and injury. Gait will be assessed by Dynamic Gait index in the same manner. All patients will be followed up with the therapist regularly twice a week for 30 minutes session each for a duration of 8 weeks.
Detailed Description
Objective To determine the effects of PNF and Gait Training Exercises on Balance and Gait in diabetic neuropathy patients Hypothesis Null hypothesis : There is no difference between PNF and Gait Training Exercises.
Alternative hypothesis : There is difference between PNF and Gait Training Exercises
Methodology (Design, sample size, sampling technique, inclusion and exclusion criteria and tool) Study design: This study is Randomized Clinical Trial Sample size: Sample size will be 40 (Two groups of 20 each) Assumed standard deviation=6.5 Confidence interval= 0.95 Desired precision=2 Calculated by epitool. Sampling technique: Convenient sampling will be used to collect data. Study design setting: Data will be conducted from Hospital wards and Outpatient departments
Inclusion Criteria:
Both male and female in the age group Patients suffering from Diabetes Mellitus (Type 1, Type 2), suffering From effects of diabetic neuropathy such as Gait instability, imbalance, numbness, tingling, Paresthesia in lower limbs for a duration of at least three months.
HbA1c more than 7 from 6 months.
Score higher than 7 out of 15 in the Michigan Neuropathy questionnaire scale and Examination score higher than 2.5.
Exclusion Criteria:
Patients suffering from significant CNS dysfunctions.
Musculoskeletal deformities
Vestibular dysfunction
Internal ear infections
Complete sensory loss
Hypoglycemia
Lower extremity arthritis or pain that limits standing or weight bearing. Data collection procedure All 40 patients will be explained in detail about the study procedure. Informed consent will be taken. Patients will be divided in two groups each consisting of 20 people.
Subjects will be evaluated using the Michigan Neuropathy Screening Questionnaire (screening tool) . One group will be tested by PNF techniques and the second group will be tested by Gait Training exercises.
PNF techniques will comprise of Warm up, Rhythmic stabilization, Hold Relax, Contract Relax and light exercises and performed on three muscle groups ( Hamstring, Quad and Calf).
Gait Training exercises will comprise of One Foot Balancing, Leg raises, Heel raises, Tight-rope Walking.
Balance will be assessed by Berg Balance scale (BBS) and Tinetti scale before, during and after the study to assess risk of fall and injury. Gait will be assessed by Dynamic Gait index in the same manner. All patients will be followed up with the therapist regularly twice a week for 30 minutes session each for a duration of 8 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathies
Keywords
PNF, DGI, BBS, TAT, MNSI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pnf exercises
Arm Type
Experimental
Arm Description
warm up, rhythmic stabilization, hold relax, contract relax and light exercises performed on three muscle groups
Arm Title
Gait training exercises
Arm Type
Experimental
Arm Description
exercises comprised of one foot balancing, leg raises, heel raises, tight-rope walking.
Intervention Type
Other
Intervention Name(s)
Pnf exercises
Intervention Description
PNF techniques will comprise of Warm up, Rhythmic stabilization, Hold Relax, Contract Relax and light exercises and performed on three muscle groups ( Hamstring, Quad and Calf).
20 participants will be followed up with the therapist regularly twice a week for 30 minutes session each for a duration of 8 weeks.
Intervention Type
Other
Intervention Name(s)
Gait training exercises
Intervention Description
gait Training exercises comprised of one foot balancing, leg raises, heel raises, tight-rope walking. 20 participants will be followed up with the therapist regularly twice a week for 30 minutes session each for a duration of 8 weeks.
Primary Outcome Measure Information:
Title
tinnete scale
Description
The test requires a hard armless chair, a stopwatch and also, a 15 feet even and uniform walkway. It has 2 sections: one assesses balance abilities in a chair and also in standing; the other assesses dynamic balance during gait on a 15 feet even walkway.Next, the patient will have to walk a few meters at a normal speed, followed by turning and walking back at a "fast but safe" speed. The patient will then sit back down. As well as in the first part of the test, there are some points the evaluator has to look at. These are the length and height of the steps, the symmetry and continuity of the steps and straightness of the trunk.
During this test, the patient can use any assistive devices (walking stick, crutches, zimmer frame) they would normally use
Time Frame
8 weeks
Title
Berg Balance Scale
Description
Document each task and/or give instructions as written. When scoring, please record the lowest response category that applies for each item.
In most items, the subject is asked to maintain a given position for a specific time. Progressively more points are deducted if:
the time or distance requirements are not met the subject's performance warrants supervision the subject touches an external support or receives assistance from the examiner The subject should understand that they must maintain their balance while attempting the tasks. The choices of which leg to stand on or how far to reach are left to the subject. Poor judgment will adversely influence the performance and the scoring.
Equipment required for testing is a stopwatch or watch with a second hand, and a ruler or other indicator of 2, 5, and 10 inches. Chairs used during testing should be a reasonable height. Either a step or a stool of average step height may be used for item.
Time Frame
8 weeks
Title
Dynamic Gait index
Description
8 functional walking tests are performed by the subject and marked out of three according to the lowest category which applies. 24 is the total individual score possible. Scores of 19 or less have been related to increase incidence of falls.
Equipment needed
Box (Shoebox), Cones (2), Stairs, 20' walkway, 15" wide
Completion Time
15 minutes
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Both male and female in the age group 40-65 • Patients suffering from Diabetes Mellitus (Type 1, Type 2), suffering From effects of diabetic neuropathy such as Gait instability, imbalance, numbness, tingling, Paresthesia in lower limbs for a duration of at least three months.
HbA1c more than 7 from 6 months.
Score higher than 7 out of 15 in the Michigan Neuropathy questionnaire scale and Examination score higher than 2.5.
Exclusion Criteria:
Patients suffering from significant CNS dysfunctions.
Musculoskeletal deformities
Vestibular dysfunction
Internal ear infections
Complete sensory loss
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sumera Azam, Mphil
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Park Teaching Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
042
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
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PNF and Gait Training on Balance and Gait in Diabetic Neueopathy Patients
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