Trial Outcomes & Findings for Effects of Foot Muscle Strengthening in Daily Activity in Diabetic Neuropathic Patients (NCT NCT02790931)

Results Overview

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Recruitment status

COMPLETED

Study phase

NA

Target enrollment

78 participants

Primary outcome timeframe

12 weeks

Results posted on

2024-12-27

Participant Flow

It was enrolled 78 participants (1 more than the protocol) because the main research intended to keep the number of participants in each group equal.

Participant milestones

Participant milestones
Measure	Intervention Group Patients will receive a physical therapy intervention in groups twice/wk, and using a software twice/ wk for 3 months. Intervention Group: Patients will receive a physical therapy intervention in groups twice/wk, and using a software twice/ wk for 3 months, for foot and ankle strengthening, stretching and functional training. They must continue to exercise at home twice a week with the software supervision for one year.	Control Group Patients will not receive any exercise treatment, will not have acess to the software, but they will keep their recommended clinical treatment.
Overall Study STARTED	39	39
Overall Study COMPLETED	15	19
Overall Study NOT COMPLETED	24	20

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Group n=39 Participants Patients will receive a physical therapy intervention in groups twice/wk, and using a software twice/ wk for 3 months. Intervention Group: Patients will receive a physical therapy intervention in groups twice/wk, and using a software twice/ wk for 3 months, for foot and ankle strengthening, stretching and functional training. They must continue to exercise at home twice a week with the software supervision for one year.	Control Group n=39 Participants Patients will not receive any exercise treatment, will not have acess to the software, but they will keep their recommended clinical treatment.	Total n=78 Participants Total of all reporting groups
Age, Continuous	61.5 years STANDARD_DEVIATION 11.7 • n=39 Participants	60.1 years STANDARD_DEVIATION 8.9 • n=39 Participants	60.8 years STANDARD_DEVIATION 10.3 • n=78 Participants
Sex: Female, Male Female	22 Participants n=39 Participants	21 Participants n=39 Participants	43 Participants n=78 Participants
Sex: Female, Male Male	17 Participants n=39 Participants	18 Participants n=39 Participants	35 Participants n=78 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Brazil	39 participants n=39 Participants	39 participants n=39 Participants	78 participants n=78 Participants
Daily physical activity	8.092 Total Steps per week STANDARD_DEVIATION 4.230 • n=39 Participants	7.641 Total Steps per week STANDARD_DEVIATION 4.087 • n=39 Participants	7.866 Total Steps per week STANDARD_DEVIATION 4158 • n=78 Participants
Fast gait speed	1.5 m/s STANDARD_DEVIATION 0.2 • n=39 Participants	1.5 m/s STANDARD_DEVIATION 0.3 • n=39 Participants	1.5 m/s STANDARD_DEVIATION 0.25 • n=78 Participants
Self-selected gait speed	1.1 m/s STANDARD_DEVIATION 0.2 • n=39 Participants	1.0 m/s STANDARD_DEVIATION 0.1 • n=39 Participants	1.0 m/s STANDARD_DEVIATION 0.15 • n=78 Participants
Height	1.6 m STANDARD_DEVIATION 0.08 • n=39 Participants	1.6 m STANDARD_DEVIATION 0.09 • n=39 Participants	1.6 m STANDARD_DEVIATION 0.08 • n=78 Participants
Body mass	77.3 kg STANDARD_DEVIATION 14.0 • n=39 Participants	80.8 kg STANDARD_DEVIATION 16.4 • n=39 Participants	79 kg STANDARD_DEVIATION 15.2 • n=78 Participants

PRIMARY outcome

Timeframe: 12 weeks

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Outcome measures

Outcome measures
Measure	Intervention Group n=22 Participants Patients will receive a physical therapy intervention in groups twice/wk, and using a software twice/ wk for 3 months. Intervention Group: Patients will receive a physical therapy intervention in groups twice/wk, and using a software twice/ wk for 3 months, for foot and ankle strengthening, stretching and functional training. They must continue to exercise at home twice a week with the software supervision for one year.	Control Group n=12 Participants Patients will not receive any exercise treatment, will not have acess to the software, but they will keep their recommended clinical treatment.
Daily Physical Activity	8744 number of steps per week Standard Deviation 810	7373 number of steps per week Standard Deviation 1010

PRIMARY outcome

Timeframe: 12 weeks

self selected gait speed shod walking velocity in a walkway

Outcome measures

Outcome measures
Measure	Intervention Group n=24 Participants Patients will receive a physical therapy intervention in groups twice/wk, and using a software twice/ wk for 3 months. Intervention Group: Patients will receive a physical therapy intervention in groups twice/wk, and using a software twice/ wk for 3 months, for foot and ankle strengthening, stretching and functional training. They must continue to exercise at home twice a week with the software supervision for one year.	Control Group n=17 Participants Patients will not receive any exercise treatment, will not have acess to the software, but they will keep their recommended clinical treatment.
Self Selected Gait Speed	1.06 m/s Standard Deviation 0.04	1.00 m/s Standard Deviation 0.04

PRIMARY outcome

Timeframe: 12 weeks

Fast gait speed shod walking velocity in a walkway

Outcome measures

Outcome measures
Measure	Intervention Group n=24 Participants Patients will receive a physical therapy intervention in groups twice/wk, and using a software twice/ wk for 3 months. Intervention Group: Patients will receive a physical therapy intervention in groups twice/wk, and using a software twice/ wk for 3 months, for foot and ankle strengthening, stretching and functional training. They must continue to exercise at home twice a week with the software supervision for one year.	Control Group n=17 Participants Patients will not receive any exercise treatment, will not have acess to the software, but they will keep their recommended clinical treatment.
Fast Gait Speed	1.68 m/s Standard Deviation 0.06	1.49 m/s Standard Deviation 0.06

SECONDARY outcome

Timeframe: 12 weeks

Score of the classification of the plantar ulcer risk (IWG diabetic foot)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Score of the Foot Health Status questionnaire - BRAZIL

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Hallux and lesser toes force measured by a pressure plate

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 12 weeks

Foot joints and plantar arch motion, ankle range of motion, and maximum ankle extension and flexion during gait

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 12 weeks

Peak joint moment and eccentric and concentric power by inverse dynamic calculations

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

New cases of foot plantar ulcers

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Evaluation of the tactile sensitivity of four plantar areas with 10g monofilament

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Evaluation of the vibration sensitivity with tuning fork

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Score of the Michigan Neuropathy Screening Instrument questionnaire Michigan Neuropathy Screening Instrument (MNSI)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Manual goniometry of the range of motion of flexion and extension of the metatarsophalangeal joint of the hallux and ankle.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

EQ-5D score of the quality of life of the patient

Outcome measures

Outcome data not reported

Adverse Events

Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Isabel de Camargo Neves Sacco

University of Sao Paulo

Phone: +551130918426

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place