Diabetic Peripheral NeuropathyNCT07575113
Comparison of Otago and Beat it Program on Balance, Gait and QOL in Diabetic Neuropathy
A study testing Otago Program and BEAT it Program in people with Diabetic Peripheral Neuropathy, run by Riphah International University at 1 site in Pakistan.
Trial summary
this study aims to compare the effects of Otago exercise program and BEAT IT program on balance, gait and quality of life in patients with diabetic peripheral neuropathy. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- Otago Program and BEAT it Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 15 May 2026to 15 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- physician-diagnosed type 2 diabetes, with peripheral neuropathy (defined by Michigan Neuropathy Screening Instrument questionnaire score of 5 or greater) the ability to walk independently for 20 m (97).
- Having score between 46 to 52 (out of a total of 56 points) on the BBS
Who cannot join
- fracture of the lower limb within the 6 months before the study
- diabetic ulcer, infection or partial amputation in feet
- disease or functional impairment of auditory, vestibular system
- Dementia or inability to give consistent information
- History of surgical procedure at the knee, ankle, or hip or indication of surgery throughout the intervention period malignancy, other neurological or orthopedic impairments (such as stroke, poliomyelitis, rheumatoid arthritis, prosthesis, or severe osteoarthritis), major vascular complications (venous or arterial ulcers), severe retinopathy, or severe nephropathy that causes edema or needs hemodialysis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
THQ hospital
Lahore, Punjab Province, 54500
Javeria Ghazal, MS, +923335154664, javeria.ghazal@riphah.edu.pk
Sania Hassan, MS
About this study
Official title: Comparative Effects of Otago Exercise Program and Beat it Program on Balance, Gait and Quality of Life in Patients With Diabetic Peripheral Neuropathy
this study aims to compare the effects of Otago exercise program and BEAT IT program on balance, gait and quality of life in patients with diabetic peripheral neuropathy.
Read the detailed description
Limited studies have been conducted to assess gait and quality of life. Most of the studies related to the Otago exercise program conducted in the geriatric population, stroke, Parkinson's, alcoholic neuropathy, chronic inflammatory polyneuropathy, and so on, a few studies conducted on diabetes, however up to the researcher's knowledge its effect on diabetic neuropathy has not been found. Similarly, studies related to the BEAT IT Program conducted in cancer patients and diabetes populations. Hence there is a need for comparative study on Otago exercise program and BEAT IT program to assess balance, gait and quality of life in patients with diabetic peripheral neuropathy
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- Otago Program, BEAT it Program
- Keywords
- Balance, Gait, Quality of life, Diabetic Peripheral Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Otago ProgramOther
The program included: 5 Strengthening exercises and 12 balance exercises. 30-40 min, 4x/week for 8 weeks.
Balance Exercises:
Knee bends Backwards walking Walking and turning around Sideways walking Tandem stance (heel toe stance) Tandem walk (heel toe walk) One leg stance Heel walking Toe walk Heel toe walking backwards Sit to stand Stair walking
Strength exercises:
Knee extensor Knee flexor Hip adductor Ankle planter flexors (calf raises) Ankle dorsiflexors (toe raises)
BEAT it ProgramOther
Strengthening exercises Toe spreading Ankle pump Mini wall squats Slow march in standing Knee with pillow press up Bridging Step up and down on stair 1st step Toe curls Stretching Hamstring stretch Dorsiflexors and planter flexors stretch Quads stretch Biceps stretch Triceps stretch Balance exercises Leg front and back swinging Weight shifting front and back Leg sideways Sideway alternate step Tandem stand Alternate heel toe raises Sessions were performed;
- for 45 to 60 minutes/ day.
- 4 times per week for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Otago program | Active comparator | Participants performed a combination of warm-up, strengthening, balance, and aerobic exercises at home. Receives: Other: Otago Program |
| BEAT it program | Experimental | Participants performed moderate-intensity aerobic, resistance, balance, and flexibility exercises, along with education on diabetes self-management. The exercises were designed to be completed at home using minimal equipment or household items Receives: Other: BEAT it Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
4 Stage Balance Test
The Four Stage Balance Test is a validated measure recommended to evaluate static balance. Four standing positions get progressively harder to maintain.
- Stand with your feet side-by-side
- Place the instep of one foot so it is touching the big toe of the other foot.
- Tandem stance Place one foot in front of the other, heel touching toes
- Stand on one foot. Reliability 0.66, Sensitivity (60%-67%), Specificity (71%-76%)
Measured: 8th week
Mini BESTest
This test measures dynamic balance, functional mobility, and gait. The Mini-BESTest, the shortened form of BESTest, contains only 14 different tasks and involves four sub-sections: anticipatory postural adjustments, postural response to external perturbations, sensory orientation, and stability in gait. Two items of Mini-BESTest are assessed bilaterally, but only the lower score was added to the maximum score of 28 points, which results from grading based on a 3-point ordinal scale ranging from 0 (severe balance impairment) to 2 (no balance impairment) (108). Reliability 0.98; Validity 0.65.
Measured: 8th week
Functional Reach Test
FRT is used to evaluate anticipatory balance which correlates with fall risks. This test measures the margin of stability along with the ability to measure balance during a functional task. Reliability 0.89; Sensitivity 76%; Specificity 34%
Measured: 8th week
Functional Gait Assessment
The FGA has been validated for the assessment of balance in people with vestibular dysfunction, community-dwelling older adults, patients with stroke, and patients with Parkinson disease. The FGA has good reliability (interrater reliability: intraclass correlation coefficient [ICC]=.74; interrater reliability: ICC=.86 to .93) and internal consistency (Cronbach alpha=.79)
Measured: 8th week
Norfolk Quality of Life-Diabetic Neuropathy (QOL-DN) questionnaire
The Norfolk Quality-of Life Diabetic Neuropathy tool (QOL-DN) has been found to be reliable across many different populations. This comprehensive tool has demonstrated sensitivity to both small and large fiber impairment while also detecting improvements in neuropathy. Intra class Reliability >0.9; Internal Consistency >0.6
Measured: 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start15 May 2026 (estimated)
- Primary completion30 Aug 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral NeuropathyStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Javeria Ghazal, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07575113
- Sponsor's protocol ID
- REC/RCR &AHS/24/0296
- Status last verified
- May 2026
- First submitted
- 23 Feb 2026
- Last updated
- 8 May 2026
- 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 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Otago Exercise Program and Beat it Program on Balance, Gait and Quality of Life in Patients With Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT07575113
- Acronym / sponsor ID
- REC/RCR &AHS/24/0296
- Conditions
- Diabetic Peripheral Neuropathy
- Keywords
- Balance, Gait, Quality of life, Diabetic Peripheral Neuropathy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 8 May 2026 (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.
this study aims to compare the effects of Otago exercise program and BEAT IT program on balance, gait and quality of life in patients with diabetic peripheral neuropathy.
Detailed description
Limited studies have been conducted to assess gait and quality of life. Most of the studies related to the Otago exercise program conducted in the geriatric population, stroke, Parkinson's, alcoholic neuropathy, chronic inflammatory polyneuropathy, and so on, a few studies conducted on diabetes, however up to the researcher's knowledge its effect on diabetic neuropathy has not been found. Similarly, studies related to the BEAT IT Program conducted in cancer patients and diabetes populations. Hence there is a need for comparative study on Otago exercise program and BEAT IT program to assess balance, gait and quality of life in patients with diabetic peripheral neuropathy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Otago program | Active comparator | Other: Otago ProgramParticipants performed a combination of warm-up, strengthening, balance, and aerobic exercises at home. |
| BEAT it program | Experimental | Other: BEAT it ProgramParticipants performed moderate-intensity aerobic, resistance, balance, and flexibility exercises, along with education on diabetes self-management. The exercises were designed to be completed at home using minimal equipment or household items |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- physician-diagnosed type 2 diabetes, with peripheral neuropathy (defined by Michigan Neuropathy Screening Instrument questionnaire score of 5 or greater) the ability to walk independently for 20 m (97).
- Having score between 46 to 52 (out of a total of 56 points) on the BBS
Key exclusion criteria (5 listed)
- fracture of the lower limb within the 6 months before the study
- diabetic ulcer, infection or partial amputation in feet
- disease or functional impairment of auditory, vestibular system
- Dementia or inability to give consistent information
- History of surgical procedure at the knee, ankle, or hip or indication of surgery throughout the intervention period malignancy, other neurological or orthopedic impairments (such as stroke, poliomyelitis, rheumatoid arthritis, prosthesis, or severe osteoarthritis), major vascular complications (venous or arterial ulcers), severe retinopathy, or severe nephropathy that causes edema or needs hemodialysis
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 |
|---|---|---|
| Otago ProgramThe program included: 5 Strengthening exercises and 12 balance exercises. 30-40 min, 4x/week for 8 weeks. Balance Exercises: Knee bends Backwards walking Walking and turning around Sideways walking Tandem stance (heel toe stance) Tandem walk (heel toe walk) One leg stance Heel walking Toe walk Heel toe walking backwards Sit to stand Stair walking Strength exercises: Knee extensor Knee flexor Hip adductor Ankle planter flexors (calf raises) Ankle dorsiflexors (toe raises) | Other | Otago program |
| BEAT it ProgramStrengthening exercises Toe spreading Ankle pump Mini wall squats Slow march in standing Knee with pillow press up Bridging Step up and down on stair 1st step Toe curls Stretching Hamstring stretch Dorsiflexors and planter flexors stretch Quads stretch Biceps stretch Triceps stretch Balance exercises Leg front and back swinging Weight shifting front and back Leg sideways Sideway alternate step Tandem stand Alternate heel toe raises Sessions were performed; * for 45 to 60 minutes/ day. * 4 times per week for 8 weeks | Other | BEAT it program |
Primary outcome
4 Stage Balance Test
Time frame: 8th week
The Four Stage Balance Test is a validated measure recommended to evaluate static balance. Four standing positions get progressively harder to maintain. 1. Stand with your feet side-by-side 2. Place the instep of one foot so it is touching the big toe of the other foot. 3. Tandem stance Place one foot in front of the other, heel touching toes 4. Stand on one foot. Reliability 0.66, Sensitivity (60%-67%), Specificity (71%-76%)
Mini BESTest
Time frame: 8th week
This test measures dynamic balance, functional mobility, and gait. The Mini-BESTest, the shortened form of BESTest, contains only 14 different tasks and involves four sub-sections: anticipatory postural adjustments, postural response to external perturbations, sensory orientation, and stability in gait. Two items of Mini-BESTest are assessed bilaterally, but only the lower score was added to the maximum score of 28 points, which results from grading based on a 3-point ordinal scale ranging from 0 (severe balance impairment) to 2 (no balance impairment) (108). Reliability 0.98; Validity 0.65.
Functional Reach Test
Time frame: 8th week
FRT is used to evaluate anticipatory balance which correlates with fall risks. This test measures the margin of stability along with the ability to measure balance during a functional task. Reliability 0.89; Sensitivity 76%; Specificity 34%
Functional Gait Assessment
Time frame: 8th week
The FGA has been validated for the assessment of balance in people with vestibular dysfunction, community-dwelling older adults, patients with stroke, and patients with Parkinson disease. The FGA has good reliability (interrater reliability: intraclass correlation coefficient [ICC]=.74; interrater reliability: ICC=.86 to .93) and internal consistency (Cronbach alpha=.79)
Norfolk Quality of Life-Diabetic Neuropathy (QOL-DN) questionnaire
Time frame: 8th week
The Norfolk Quality-of Life Diabetic Neuropathy tool (QOL-DN) has been found to be reliable across many different populations. This comprehensive tool has demonstrated sensitivity to both small and large fiber impairment while also detecting improvements in neuropathy. Intra class Reliability >0.9; Internal Consistency >0.6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- 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.
Javeria Ghazal, MS 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 Otago Program and BEAT it Program in people with Diabetic Peripheral Neuropathy, 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 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: opening soon, as of the sponsor's last update on 8 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muneeb khan, PhD (+92336799611, muneeb.khan@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
4 Stage Balance Test (time frame: 8th week). The study lists 5 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 8 May 2026.