Diabetic Peripheral Neuropathy (DPN)NCT04832464
BRACE(Balance, Resistance, Aerobic and Cognitive Exercise) Protocol for Diabetic).Peripheral Neuropathic Patients.
A study testing RACE Protocol: Balance training along with resistance, aerobic and cognitive exercises. in people with Diabetic Peripheral Neuropathy (DPN), run by Riphah International University at 1 site in Pakistan.
Trial summary
The purpose of the study is to determine the effects of the BRACE( Balance, Resistance, Aerobic and Cognitive Exercise) protocol for balance training in patients with Diabetic Peripheral Neuropathy. A Randomized Control Trial is being conducted at Railways General Hospital, Rawalpindi. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy (DPN)
- What is being tested?
- RACE Protocol: Balance training along with resistance, aerobic and cognitive exercises.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Mar 2021to 27 Feb 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with type-2 Diabetes
- Diabetes of more than 5 years of the duration
Who cannot join
- Patients have vertebrobasilar insufficiency (tested by VBI tests)
- Atlanto-axial instability (tested by sharp purser test)
- Osteoporosis
- Rheumatoid arthritis
- Neuropathies
- Recent surgeries
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Riphah International University
Islamabad, Fedral, 44000
Imran Amjad, PhD, imran.amjad@riphah.edu.pk
Azka Tariq, MSNMPT*
About this study
Official title: Effects of BRACE (Balance, Resistance, Aerobic and Cognitive Exercise) Protocol for Balance Training in Patients With Diabetic Peripheral Neuropathy.
The purpose of the study is to determine the effects of the BRACE( Balance, Resistance, Aerobic and Cognitive Exercise) protocol for balance training in patients with Diabetic Peripheral Neuropathy. A Randomized Control Trial is being conducted at Railways General Hospital, Rawalpindi. The sample size was calculated through the open epi tool. A total of 60 patients are divided into two groups, 30 participants in the experimental group and 30 participants in the control group. The study duration will be six months. The sampling technique applied was simple random sampling for recruitment and group randomization using the sealed envelope method. Patients with the age of 40-65 years having type II diabetes for more than 5 years are included in the study. Tools used in the study are Berg balance scale, timed up and go test, functional reach test, Montreal Cognitive Assessment scale (MOCA), and force plate. Data will be analyzed through Statistical Package for the Social Sciences (SPSS), version 21.
Read the detailed description
American Diabetic Association (ADA) defined Diabetes mellitus as a group of metabolic diseases characterized by hyperglycemia resulting from defects in insulin secretion, insulin action, or both. The chronic hyperglycemia of diabetes is associated with dysfunction of various organs, especially the eyes, kidneys, nerves, heart, and blood vessels.
Most common among the neuropathies are chronic sensorimotor distal symmetric polyneuropathy (DPN) and autonomic neuropathies. According to ADA(American Diabetes Association), DPN(Diabetic Peripheral Neuropathy) is "the presence of symptoms and/or signs of peripheral nerve dysfunction in people with diabetes after exclusion of other causes. It is estimated that 60% to 70% of individuals with diabetes have mild to severe forms of nervous system damage.
DPN(Diabetic Peripheral Neuropathy) causes decreased sensation, proprioception, reflexes, and strength in the lower extremities, leading to balance dysfunction. Physical therapy interventions utilized to reduce the balance dysfunction can range from restoration of the health of the neurons to sensory integration to compensatory strategies. Various treatment protocols include improving circulation, the guided practice of integrating internal and external sensory input, education on sensation loss and fall risk, instruction on home modifications, and introduction of assistive devices to minimize balance dysfunction.
A systematic and evidence-based search of relevant literature was performed by utilizing PubMed and Google Scholar as search engines.
Search term for the initial literature review was Diabetes mellitus, the prevalence of DPN(diabetic peripheral neuropathy), causes of peripheral neuropathies and loss of balance, the pathophysiology of diabetes-related peripheral neuropathy, treatment options for balance training, strengthening lower extremities, aerobics, cognitive approach. The search was limited to papers in English preferably published since 2000 with full text available. Different studies were available regarding balance exercises and their effects but limited data was available regarding BRACE ( Balance, Resistance, Anaerobic, and Cognitive Exercise) protocol as a whole in recent years.
Balance exercises are feasible and safe and have the potential to improve balance and gait. These should be used as supportive therapy for DPN patients. Lower extremity resistance (strengthening) exercises are fairly recommended for clinical use in treating balance dysfunction in patients with DPN than monochromatic infrared energy therapy, vibrating insoles, and use of a cane.
Previously, walking and weight-bearing were considered contraindicated in DPN patients to avoid foot ulcers, deformity, or fall risk. Emerging research has revealed positive adaptations in response to overload stress in these people, including evidence for peripheral neuroplasticity in animal models and early clinical trials.
According to WHO estimation, a number of individuals approximately 47 million worldwide have cognitive impairments which will increase to 75 million by 2030. A 2 years longitudinal study in Korea showed a significant association between cognitive decline and physical activity. Pain interference may be reduced following an aerobic exercise intervention among people with painful DPN, without a change in pain intensity.
Although, multiples researches have shown the effects of particular interventions on DPN still there is a lack of multi-component interventional studies to show the effects on balance issues.
- Conditions
- Diabetic Peripheral Neuropathy (DPN)
- Being tested
- RACE Protocol: Balance training along with resistance, aerobic and cognitive exercises.
- Keywords
- Diabetic Peripheral Neuropathy, Balance training, Strengthening, Cognitive exercises, Aerobics exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RACE Protocol: Balance training along with resistance, aerobic and cognitive exercises.Other
Also called Balance Training Home plan
therapy for the preservation, enhancement, or restoration of movement and physical function impaired or threatened by disease, injury, or disability that utilizes therapeutic exercise, physical modalities (such as massage and electrotherapy), assistive devices, and patient education and training.
| Study group | Role | What they receive |
|---|---|---|
| Balance Training Home plan | Active comparator | The Control group is undergoing balance training only, 3 days a week, and will be for 8 weeks. Balance training includes 10minutes of warm-up and 30 minutes of balance exercises. A force plate will be used to measure the postural sways. Measurements will be taken at a base-line, after the first session, at mid-level (4th week) and at the end (8th week).
These exercises include Static Balance exercises(1-2weeks): Romberg with eyes open \& close, Tandem standing with eyes open \& close with alternate feet, Single leg stance.
Static/ Dynamic/ Anticipatory Postural Control (3-4weeks): Sit to Stand, FRT( forward reach test) that is forward, sideways, cross reach, and timed up and go test.
Static/ Dynamic/ Anticipatory? Reactive Postural Control (5-6weeks): Perturbations:
Controlled by the therapist in sitting \& standing, Throwing a ball, kicking a ball.
(7-8weeks): Combination of All Receives: Other: RACE Protocol: Balance training along with resistance, aerobic and cognitive exercises. |
| BRACE Protocol: Balance training along with resistance, aerobic and cognitive excercises | Experimental | BRACE protocol for balance training 3 days a week for 8 consecutive weeks on alternate days.
These exercises include Static Balance exercises(1-2weeks) plus Chair rise 30 sec without using hands, 6-minute walk, count reverse from 50, push the wall, and reverse count from 20.
Static, dynamic, anticipatory postural control (3-4weeks) plus Stair climbing without using rails, marching in space, remember 5 words, name 5 animals, repeat 5 words, spell the word like APPLE, spell backward again.
Static, dynamic, anticipatory postural control (5-6weeks) plus Squatting, cycling, count even numbers from 1-50.
calculation: Addition, subtraction, multiplication, division. (7-8weeks): Combination of all. Receives: Other: RACE Protocol: Balance training along with resistance, aerobic and cognitive exercises. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
To objectively determine a patient's ability (or inability) to safely balance during a series of pre-determined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function with a total of 56 scores. This scale is interpreted as 0-20 on the BBS represents balance impairment; 21-40 on the BBS represents acceptable balance; 41-56 on the BBS represents a good balance. Measurements will be taken at a base-line, after the first session, at mid-level (4th week) and at the end (8th week).
Measured: Up to 8 weeks
Secondary outcomes (6)
TUG test
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance.[1]
It uses the time that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees. The scores of ten seconds or less indicate normal mobility, 11-20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention. A score of 30 seconds or more suggests that the person may be prone to falls.
Measurements will be taken at a base-line, after the first session, at mid-level (4th week) and at the end (8th week).
Measured: Up to 8 weeks
FRT test
Functional Reach Test (FRT) is a clinical outcome measure and assessment tool for ascertaining dynamic balance in one simple task. In standing, measures the distance between the length of an outstretched arm in a maximal forward reach, while maintaining a fixed base of support.
This information is correlated with the risk of falling.
Measurement Interpretation:
10"/25 cm or greater Low risk of falls; 6"/15cm to 10"/25cm Risk of falling is 2x greater than normal; 6"/15cm or less Risk of falling is 4x greater than normal; Unwilling to reach Risk of falling is 8x greater than normal. Measurements will be taken at a base-line, after the first session, at mid-level (4th week) and at the end (8th week).
Measured: Up to 8 weeks
MoCA
The Montreal Cognitive Assessment (MoCA) is a widely used screening assessment for detecting cognitive impairment. MoCA scores range between 0 and 30. A score of 26 or over is considered to be normal. In a study, people without cognitive impairment score an average of 27.4; people with mild cognitive impairment (MCI) score an average of 22.1; people with Alzheimer's disease score an average of 16.2.
Measurements will be taken at a base-line, after the first session, at mid-level (4th week) and at the end (8th week).
Measured: Up to 8 weeks
Postural sway
A force plate will be used to measure the postural sways. Measurements will be taken at a base-line, after the first session, at mid-level (4th week) and at the end (8th week).
Measured: Up to 8 weeks
Gait and Posture assessment by application
A mobile application (Gait and posture) will be used to measure the postural sways and balance. Measurements will be taken at a base-line, after the first session, at mid-level (4th week) and at the end (8th week).
Measured: Up to 8 weeks
Michigan Neuropathy Screening Instrument
The Michigan Neuropathy Screening Instrument (MNSI) is designed to screen for the presence of diabetic neuropathy. The first part of the screening instrument, the history questionnaire, consists of 15 self-administered "yes or no" questions on foot sensation including pain, numbness, and temperature sensitivity. A higher score (out of a maximum of 13 points) indicates more neuropathic symptoms. The second part of the MNSI is a brief physical assessment (completed by health professionals).
Patients screening positive on the clinical portion of the MNSI (greater than 2 points on a 10 point scale) are considered neuropathic and referred for further evaluation.
A force plate will be used to measure the postural sways. Measurements will be taken at a base-line, after the first session, at mid-level (4th week) and at the end (8th week).
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start30 Mar 2021
- Primary completion27 Feb 2022 (estimated)
- Study completion27 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Diabetic Peripheral Neuropathy (DPN)Studies 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
- Model description
- Parallel assignment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Imran Amjad, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04832464
- Sponsor's protocol ID
- REC/00548 Azka Tariq
- Status last verified
- Sep 2021
- First submitted
- 29 Mar 2021
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pandey S, Raj IJS. Comparison of Game Based Rehabilitation and Mixed Sport Training on Balance in Diabetic Neuropathy: Lovely Professional University; 2017
American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2013 Jan;36 Suppl 1(Suppl 1):S67-74. doi: 10.2337/dc13-S067. No abstract available.
PubMed 23264425O'Sullivan SB, Schmitz TJ, Fulk G. Physical rehabilitation: FA Davis; 2019
Kluding PM, Bareiss SK, Hastings M, Marcus RL, Sinacore DR, Mueller MJ. Physical Training and Activity in People With Diabetic Peripheral Neuropathy: Paradigm Shift. Phys Ther. 2017 Jan 1;97(1):31-43. doi: 10.2522/ptj.20160124.
PubMed 27445060Ahmad I, Hussain E, Singla D, Verma S, Ali K. Balance Training in Diabetic Peripheral Neuropathy: A Narrative Review. JSM Diabetol Manag. 2017;2(1):1-9
Wallin A, Kettunen P, Johansson PM, Jonsdottir IH, Nilsson C, Nilsson M, Eckerstrom M, Nordlund A, Nyberg L, Sunnerhagen KS, Svensson J, Terzis B, Wahlund LO, Georg Kuhn H. Cognitive medicine - a new approach in health care science. BMC Psychiatry. 2018 Feb 8;18(1):42. doi: 10.1186/s12888-018-1615-0.
PubMed 29422020Kiani N, Marryam M, Malik AN, Amjad I. The effect of aerobic exercises on balance in diabetic neuropathy patients. Journal Of Medical Sciences. 2018;26(2):141-5
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of BRACE (Balance, Resistance, Aerobic and Cognitive Exercise) Protocol for Balance Training in Patients With Diabetic Peripheral Neuropathy.
- ClinicalTrials.gov ID
- NCT04832464
- Acronym / sponsor ID
- REC/00548 Azka Tariq
- Conditions
- Diabetic Peripheral Neuropathy (DPN)
- Keywords
- Diabetic Peripheral Neuropathy, Balance training, Strengthening, Cognitive exercises, Aerobics exercises
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 27 Feb 2022 (estimated)
- Study completion
- 27 Feb 2022 (estimated)
- First posted
- 5 Apr 2021 (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.
The purpose of the study is to determine the effects of the BRACE( Balance, Resistance, Aerobic and Cognitive Exercise) protocol for balance training in patients with Diabetic Peripheral Neuropathy. A Randomized Control Trial is being conducted at Railways General Hospital, Rawalpindi. The sample size was calculated through the open epi tool. A total of 60 patients are divided into two groups, 30 participants in the experimental group and 30 participants in the control group. The study duration will be six months. The sampling technique applied was simple random sampling for recruitment and group randomization using the sealed envelope method. Patients with the age of 40-65 years having type II diabetes for more than 5 years are included in the study. Tools used in the study are Berg balance scale, timed up and go test, functional reach test, Montreal Cognitive Assessment scale (MOCA), and force plate. Data will be analyzed through Statistical Package for the Social Sciences (SPSS), version 21.
Detailed description
American Diabetic Association (ADA) defined Diabetes mellitus as a group of metabolic diseases characterized by hyperglycemia resulting from defects in insulin secretion, insulin action, or both. The chronic hyperglycemia of diabetes is associated with dysfunction of various organs, especially the eyes, kidneys, nerves, heart, and blood vessels.
Most common among the neuropathies are chronic sensorimotor distal symmetric polyneuropathy (DPN) and autonomic neuropathies. According to ADA(American Diabetes Association), DPN(Diabetic Peripheral Neuropathy) is "the presence of symptoms and/or signs of peripheral nerve dysfunction in people with diabetes after exclusion of other causes. It is estimated that 60% to 70% of individuals with diabetes have mild to severe forms of nervous system damage.
DPN(Diabetic Peripheral Neuropathy) causes decreased sensation, proprioception, reflexes, and strength in the lower extremities, leading to balance dysfunction. Physical therapy interventions utilized to reduce the balance dysfunction can range from restoration of the health of the neurons to sensory integration to compensatory strategies. Various treatment protocols include improving circulation, the guided practice of integrating internal and external sensory input, education on sensation loss and fall risk, instruction on home modifications, and introduction of assistive devices to minimize balance dysfunction.
A systematic and evidence-based search of relevant literature was performed by utilizing PubMed and Google Scholar as search engines.
Search term for the initial literature review was Diabetes mellitus, the prevalence of DPN(diabetic peripheral neuropathy), causes of peripheral neuropathies and loss of balance, the pathophysiology of diabetes-related peripheral neuropathy, treatment options for balance training, strengthening lower extremities, aerobics, cognitive approach. The search was limited to papers in English preferably published since 2000 with full text available. Different studies were available regarding balance exercises and their effects but limited data was available regarding BRACE ( Balance, Resistance, Anaerobic, and Cognitive Exercise) protocol as a whole in recent years.
Balance exercises are feasible and safe and have the potential to improve balance and gait. These should be used as supportive therapy for DPN patients. Lower extremity resistance (strengthening) exercises are fairly recommended for clinical use in treating balance dysfunction in patients with DPN than monochromatic infrared energy therapy, vibrating insoles, and use of a cane.
Previously, walking and weight-bearing were considered contraindicated in DPN patients to avoid foot ulcers, deformity, or fall risk. Emerging research has revealed positive adaptations in response to overload stress in these people, including evidence for peripheral neuroplasticity in animal models and early clinical trials.
According to WHO estimation, a number of individuals approximately 47 million worldwide have cognitive impairments which will increase to 75 million by 2030. A 2 years longitudinal study in Korea showed a significant association between cognitive decline and physical activity. Pain interference may be reduced following an aerobic exercise intervention among people with painful DPN, without a change in pain intensity.
Although, multiples researches have shown the effects of particular interventions on DPN still there is a lack of multi-component interventional studies to show the effects on balance issues.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Balance Training Home plan | Active comparator | Other: RACE Protocol: Balance training along with resistance, aerobic and cognitive exercises.The Control group is undergoing balance training only, 3 days a week, and will be for 8 weeks. Balance training includes 10minutes of warm-up and 30 minutes of balance exercises. A force plate will be used to measure the postural sways. Measurements will be taken at a base-line, after the first session, at mid-level (4th week) and at the end (8th week). These exercises include Static Balance exercises(1-2weeks): Romberg with eyes open \& close, Tandem standing with eyes open \& close with alternate feet, Single leg stance. Static/ Dynamic/ Anticipatory Postural Control (3-4weeks): Sit to Stand, FRT( forward reach test) that is forward, sideways, cross reach, and timed up and go test. Static/ Dynamic/ Anticipatory? Reactive Postural Control (5-6weeks): Perturbations: Controlled by the therapist in sitting \& standing, Throwing a ball, kicking a ball. (7-8weeks): Combination of All |
| BRACE Protocol: Balance training along with resistance, aerobic and cognitive excercises | Experimental | Other: RACE Protocol: Balance training along with resistance, aerobic and cognitive exercises.BRACE protocol for balance training 3 days a week for 8 consecutive weeks on alternate days. These exercises include Static Balance exercises(1-2weeks) plus Chair rise 30 sec without using hands, 6-minute walk, count reverse from 50, push the wall, and reverse count from 20. Static, dynamic, anticipatory postural control (3-4weeks) plus Stair climbing without using rails, marching in space, remember 5 words, name 5 animals, repeat 5 words, spell the word like APPLE, spell backward again. Static, dynamic, anticipatory postural control (5-6weeks) plus Squatting, cycling, count even numbers from 1-50. calculation: Addition, subtraction, multiplication, division. (7-8weeks): Combination of all. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with type-2 Diabetes
- Diabetes of more than 5 years of the duration
Key exclusion criteria (6 listed)
- Patients have vertebrobasilar insufficiency (tested by VBI tests)
- Atlanto-axial instability (tested by sharp purser test)
- Osteoporosis
- Rheumatoid arthritis
- Neuropathies
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 |
|---|---|---|
| RACE Protocol: Balance training along with resistance, aerobic and cognitive exercises.Also: Balance Training Home plantherapy for the preservation, enhancement, or restoration of movement and physical function impaired or threatened by disease, injury, or disability that utilizes therapeutic exercise, physical modalities (such as massage and electrotherapy), assistive devices, and patient education and training. | Other | BRACE Protocol: Balance training along with resistance, aerobic and cognitive excercises, Balance Training Home plan |
Primary outcome
Berg Balance Scale
Time frame: Up to 8 weeks
To objectively determine a patient's ability (or inability) to safely balance during a series of pre-determined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function with a total of 56 scores. This scale is interpreted as 0-20 on the BBS represents balance impairment; 21-40 on the BBS represents acceptable balance; 41-56 on the BBS represents a good balance. Measurements will be taken at a base-line, after the first session, at mid-level (4th week) and at the end (8th week).
6 secondary outcomes
TUG test
Time frame: Up to 8 weeks
FRT test
Time frame: Up to 8 weeks
MoCA
Time frame: Up to 8 weeks
Postural sway
Time frame: Up to 8 weeks
Gait and Posture assessment by application
Time frame: Up to 8 weeks
Michigan Neuropathy Screening Instrument
Time frame: Up to 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- BackgroundPandey S, Raj IJS. Comparison of Game Based Rehabilitation and Mixed Sport Training on Balance in Diabetic Neuropathy: Lovely Professional University; 2017
- Background: PubMed 23264425American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2013 Jan;36 Suppl 1(Suppl 1):S67-74. doi: 10.2337/dc13-S067. No abstract available.
- BackgroundO'Sullivan SB, Schmitz TJ, Fulk G. Physical rehabilitation: FA Davis; 2019
- Background: PubMed 27445060Kluding PM, Bareiss SK, Hastings M, Marcus RL, Sinacore DR, Mueller MJ. Physical Training and Activity in People With Diabetic Peripheral Neuropathy: Paradigm Shift. Phys Ther. 2017 Jan 1;97(1):31-43. doi: 10.2522/ptj.20160124.
- BackgroundAhmad I, Hussain E, Singla D, Verma S, Ali K. Balance Training in Diabetic Peripheral Neuropathy: A Narrative Review. JSM Diabetol Manag. 2017;2(1):1-9
- Background: PubMed 29422020Wallin A, Kettunen P, Johansson PM, Jonsdottir IH, Nilsson C, Nilsson M, Eckerstrom M, Nordlund A, Nyberg L, Sunnerhagen KS, Svensson J, Terzis B, Wahlund LO, Georg Kuhn H. Cognitive medicine - a new approach in health care science. BMC Psychiatry. 2018 Feb 8;18(1):42. doi: 10.1186/s12888-018-1615-0.
- BackgroundKiani N, Marryam M, Malik AN, Amjad I. The effect of aerobic exercises on balance in diabetic neuropathy patients. Journal Of Medical Sciences. 2018;26(2):141-5
- 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.
Imran Amjad, PhD 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 RACE Protocol: Balance training along with resistance, aerobic and cognitive exercises. in people with Diabetic Peripheral Neuropathy (DPN), 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 9 Sep 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, PhD ((+92)3324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (time frame: Up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04832464, which also lists 7 linked publications.
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 9 Sep 2021.