Diabetic NeuropathyNCT05243589
Effects of Proprioceptive Training in Addition to Routine Physical Therapy on Balance and Quality of Life in Patients With Diabetic Peripheral Neuropathy
A study testing Proprioceptive training and routine physical therapy in people with Diabetic Neuropathy, run by Momna Asghar at 1 site in Pakistan.
Trial summary
Objective of the study is to find out the effects of Proprioceptive training in addition to routine physical therapy on balance and quality of life in patients with Diabetic neuropathy. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Diabetic Neuropathy
- What is being tested?
- Proprioceptive training and routine physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 sitePakistan
- Study dates
- 26 Feb 2021to 5 Dec 2021
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with pre-diagnosed DM for seven years.
- Male and female patients with type 2 diabetes.
- Patients with ≥2 DPN symptoms.
- Patients scored\>2/13 on MNSI questionnaire.
Who cannot join
- Participants with Foot ulcers, Orthopedic or surgical problem in a lower limb, other neurological impairment and Major vascular complication,
- Severe vestibular dysfunction
- Participants with Severe retinopathy and Severe nephropathy,
- Inability to walk independently with or without an assistive device,
- Receiving any structured supervised physiotherapy intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Proprioceptive Training in Addition to Routine Physical Therapy on Balance and Quality of Life in Patients With Diabetic Peripheral Neuropathy: a Randomized Controlled Trial
Objective of the study is to find out the effects of Proprioceptive training in addition to routine physical therapy on balance and quality of life in patients with Diabetic neuropathy.
Alternate Hypothesis:
There will be significant difference in effects of Proprioceptive training in addition to routine physical therapy on balance and Quality of life in patients with Diabetic neuropathy.
Read the detailed description
It was a parallel designed single blinded randomized controlled trial conducted in the Green Poly Clinic Bahria town, Lahore, Pakistan using non probability convenient sampling. patients who met eligibility criteria was informed about the aim of study. consent form were signed by all participants.After baseline assessment ,participants were randomly assigned in two groups.(ratio 1:1) The calcualted sample size was 27 in each group. i.e. 54 ( 27 in each group). After adding 20% drop out the final size will become, 64( 32 in each group) using 95% level of significance and 80% power of study.
- Conditions
- Diabetic Neuropathy
- Being tested
- Proprioceptive training, routine physical therapy
- Keywords
- Neuropathy, Proprioceptive training, Balance, Quality of life, Physical therapy
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive trainingOther
Proprioceptive training included exercises on different floor textures composed of 10 stations of exercises with the objective of stimulating the sole of the foot where participants had to coordinate gait by stepping with alternate feet on markers placed on the ground and the progression was manipulated through modifications of speed and direction.
Sequence of materials was 10 cm-thick foam, wood box with beans, two-cm thick mat with a density lower than the foam, wood box with cotton, two-cm thick mat volunteers sat on a bench and trained feet flexors by grasping with the toes a towel put on the floor, Two proprioception balls was used with an eight cm diameter with external projections resting on the floor a box with grains and sandpaper. After that joint Positional Sense Exercises were performed.
routine physical therapyOther
Routine physical therapy included range of motion exercises for bilateral ankle joints (5 min.), functional balance training (15 min.) involving sit to stand (5 times); standing weight shift (5 times each); functional reach- sideway and anterior for touching targets set by the therapist (5 times each); bipedal heel rise for 20 seconds (5 times); unipedal standing for 15 seconds (5 times each) and unipedal standing with knee bending for 15 second (5 times each). Other exercises was practiced as wobble board training (6 min).
| Study group | Role | What they receive |
|---|---|---|
| group A/ routine physical therapy and proprioceptive training | Experimental | Routine physical therapy and proprioceptive training is performed Receives: Other: Proprioceptive training; Other: routine physical therapy |
| Group B/ routine physical therapy | Active comparator | Routine physical therapy Receives: Other: routine physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale (assessing change in ability to balance at baseline, 4th week and at 6th week.
It is a 14-item list with each item consisting of a five-point ordinal scale ranging from 0 to 4.0 denotes inability to complete the item, and 4 the ability to accomplish the task independently (total score range, 0-56; higher = better performance). Scores of less than 45 out of 56 are accepted as indicative of balance disorders in the elderly.
Measured: It was checked before the intervention started (after recruitment of patient) and then checked at the 4th week and then at the end of 6th weeks.
WHO Quality of Life Scale (WHOQOL BREF)( assessing change in quality of life at baseline, 4th and 6th week of intervention.
The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centers, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally.It contains a total of 26 questions. To provide a broad and comprehensive assessment, one item from each of 24 facets contained in the WHOQOL-100 has been included.
Measured: It was checked before the intervention started (after recruitment of patient) and then checked at the 4th week and then at the end of 6th weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start26 Feb 2021
- Primary completion4 Nov 2021
- Study completion5 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NeuropathyStudies of the same condition, open and under way.
- 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
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Momna Asghar
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lahore
- Responsible party
- Sponsor-investigator, Momna Asghar, University of Lahore
- Investigators
- Momna Asghar, MSPTN, Principal investigator, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243589
- Sponsor's protocol ID
- IRB-UOL-FAHS/823/2021
- Status last verified
- Feb 2022
- First submitted
- 5 Feb 2022
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Proprioceptive Training in Addition to Routine Physical Therapy on Balance and Quality of Life in Patients With Diabetic Peripheral Neuropathy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05243589
- Acronym / sponsor ID
- IRB-UOL-FAHS/823/2021
- Conditions
- Diabetic Neuropathy
- Keywords
- Neuropathy, Proprioceptive training, Balance, Quality of life, Physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Momna AsgharUniversity, hospital or other
- Collaborators
- University of Lahore
- Study start
- 26 Feb 2021 (actual)
- Primary completion
- 4 Nov 2021 (actual)
- Study completion
- 5 Dec 2021 (actual)
- First posted
- 17 Feb 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.
Objective of the study is to find out the effects of Proprioceptive training in addition to routine physical therapy on balance and quality of life in patients with Diabetic neuropathy.
Alternate Hypothesis:
There will be significant difference in effects of Proprioceptive training in addition to routine physical therapy on balance and Quality of life in patients with Diabetic neuropathy.
Detailed description
It was a parallel designed single blinded randomized controlled trial conducted in the Green Poly Clinic Bahria town, Lahore, Pakistan using non probability convenient sampling. patients who met eligibility criteria was informed about the aim of study. consent form were signed by all participants.After baseline assessment ,participants were randomly assigned in two groups.(ratio 1:1) The calcualted sample size was 27 in each group. i.e. 54 ( 27 in each group). After adding 20% drop out the final size will become, 64( 32 in each group) using 95% level of significance and 80% power of study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A/ routine physical therapy and proprioceptive training | Experimental | Other: Proprioceptive training, Other: routine physical therapyRoutine physical therapy and proprioceptive training is performed |
| Group B/ routine physical therapy | Active comparator | Other: routine physical therapyRoutine physical therapy |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with pre-diagnosed DM for seven years.
- Male and female patients with type 2 diabetes.
- Patients with ≥2 DPN symptoms.
- Patients scored\>2/13 on MNSI questionnaire.
Key exclusion criteria (5 listed)
- Participants with Foot ulcers, Orthopedic or surgical problem in a lower limb, other neurological impairment and Major vascular complication,
- Severe vestibular dysfunction
- Participants with Severe retinopathy and Severe nephropathy,
- Inability to walk independently with or without an assistive device,
- Receiving any structured supervised physiotherapy intervention.
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 |
|---|---|---|
| Proprioceptive trainingProprioceptive training included exercises on different floor textures composed of 10 stations of exercises with the objective of stimulating the sole of the foot where participants had to coordinate gait by stepping with alternate feet on markers placed on the ground and the progression was manipulated through modifications of speed and direction. Sequence of materials was 10 cm-thick foam, wood box with beans, two-cm thick mat with a density lower than the foam, wood box with cotton, two-cm thick mat volunteers sat on a bench and trained feet flexors by grasping with the toes a towel put on the floor, Two proprioception balls was used with an eight cm diameter with external projections resting on the floor a box with grains and sandpaper. After that joint Positional Sense Exercises were performed. | Other | group A/ routine physical therapy and proprioceptive training |
| routine physical therapyRoutine physical therapy included range of motion exercises for bilateral ankle joints (5 min.), functional balance training (15 min.) involving sit to stand (5 times); standing weight shift (5 times each); functional reach- sideway and anterior for touching targets set by the therapist (5 times each); bipedal heel rise for 20 seconds (5 times); unipedal standing for 15 seconds (5 times each) and unipedal standing with knee bending for 15 second (5 times each). Other exercises was practiced as wobble board training (6 min). | Other | Group B/ routine physical therapy, group A/ routine physical therapy and proprioceptive training |
Primary outcome
Berg Balance Scale (assessing change in ability to balance at baseline, 4th week and at 6th week.
Time frame: It was checked before the intervention started (after recruitment of patient) and then checked at the 4th week and then at the end of 6th weeks.
It is a 14-item list with each item consisting of a five-point ordinal scale ranging from 0 to 4.0 denotes inability to complete the item, and 4 the ability to accomplish the task independently (total score range, 0-56; higher = better performance). Scores of less than 45 out of 56 are accepted as indicative of balance disorders in the elderly.
WHO Quality of Life Scale (WHOQOL BREF)( assessing change in quality of life at baseline, 4th and 6th week of intervention.
Time frame: It was checked before the intervention started (after recruitment of patient) and then checked at the 4th week and then at the end of 6th weeks.
The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centers, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally.It contains a total of 26 questions. To provide a broad and comprehensive assessment, one item from each of 24 facets contained in the WHOQOL-100 has been included.
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 17 Feb 2022.
- Individual participant dataSharing planned: Undecided
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Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
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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.
Momna Asghar, MSPTN principal investigator
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprioceptive training and routine physical therapy in people with Diabetic Neuropathy, run by Momna Asghar 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 4 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 17 Feb 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?
Berg Balance Scale (assessing change in ability to balance at baseline, 4th week and at 6th week. (time frame: It was checked before the intervention started (after recruitment of patient) and then checked at the 4th week and then at the end of 6th weeks.). The study lists 2 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 17 Feb 2022.