Diabetic NeuropathiesNCT05593133
PNF and Gait Training on Balance and Gait in Diabetic Neueopathy Patients
A study testing Pnf exercises and Gait training exercises in people with Diabetic Neuropathies, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Diabetic Neuropathies
- What is being tested?
- Pnf exercises and Gait training exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Jan 2021to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients suffering from significant CNS dysfunctions.
- Musculoskeletal deformities
- Vestibular dysfunction
- Internal ear infections
- Complete sensory loss
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of PNF and Gait Training Exercises on Balance and Gait in Patients With Diabetic Neuropathy
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.
Read the 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.
- Conditions
- Diabetic Neuropathies
- Being tested
- Pnf exercises, Gait training exercises
- Keywords
- PNF, DGI, BBS, TAT, MNSI
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pnf exercisesOther
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.
Gait training exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pnf exercises | Experimental | warm up, rhythmic stabilization, hold relax, contract relax and light exercises performed on three muscle groups Receives: Other: Pnf exercises |
| Gait training exercises | Experimental | exercises comprised of one foot balancing, leg raises, heel raises, tight-rope walking. Receives: Other: Gait training exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
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.
Measured: 8 weeks
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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start5 Jan 2021
- Primary completion8 Sep 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NeuropathiesStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sumera Azam, Mphil, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593133
- Sponsor's protocol ID
- Maryam Rauf
- Status last verified
- Oct 2022
- First submitted
- 21 Oct 2022
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of PNF and Gait Training Exercises on Balance and Gait in Patients With Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT05593133
- Acronym / sponsor ID
- Maryam Rauf
- Conditions
- Diabetic Neuropathies
- Keywords
- PNF, DGI, BBS, TAT, MNSI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 8 Sep 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 25 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pnf exercises | Experimental | Other: Pnf exerciseswarm up, rhythmic stabilization, hold relax, contract relax and light exercises performed on three muscle groups |
| Gait training exercises | Experimental | Other: Gait training exercisesexercises comprised of one foot balancing, leg raises, heel raises, tight-rope walking. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- Patients suffering from significant CNS dysfunctions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pnf exercisesPNF 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. | Other | Pnf exercises |
| Gait training exercisesgait 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. | Other | Gait training exercises |
Primary outcome
tinnete scale
Time frame: 8 weeks
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
Time frame: 8 weeks
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
Time frame: 8 weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sumera Azam, Mphil principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pnf exercises and Gait training exercises in people with Diabetic Neuropathies, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tinnete scale (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022.