Trial Outcomes & Findings for Foot and Ankle Range of Motion (Stretching) Apparatus (NCT NCT00527748)

NCT ID: NCT00527748

Last Updated: 2017-04-21

Results Overview

Participants randomized into ARM stretching device group will experience less ankle stiffness and an increased range of motion after using the stretching device, as compared to the control group receiving traditional physiotherapy.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 26 participants
• Primary outcome timeframe: Ten weeks
• Results posted on: 2017-04-21

Participant Flow

26 participants were enrolled. While we know the number who completed the study (23), we do not know to which group/arm they were assigned. There are no other recruitment details, study results or data available as the PI left the institution without making this information available to the research department.

Participant milestones

Measure	Standard of Care or Ankle Exerciser Patient ankle range of motion will be assessed at clinic visit. They will either receive standard care physiotherapy, or use the ankle exerciser in the following manner: Subjects will train using only one combination of movement, dorsiflexion with inversion. This is done by manipulating the ring so that the medial and anterior ropes are taut. Subject will start with 3 minute warm-up. Subject will then manipulate the ring so that the foot moves into dorsiflexion with inversion until a point of tolerable discomfort is felt; subject will hold this position for 30 seconds. Stretch will be repeated 10 times, each day, for six weeks. Reassessment will be done at six weeks and 10 weeks.
Overall Study STARTED	26
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure

Standard of Care or Ankle Exerciser Patient ankle range of motion will be assessed at clinic visit. They will either receive standard care physiotherapy, or use the ankle exerciser in the following manner: Subjects will train using only one combination of movement, dorsiflexion with inversion. This is done by manipulating the ring so that the medial and anterior ropes are taut. Subject will start with 3 minute warm-up. Subject will then manipulate the ring so that the foot moves into dorsiflexion with inversion until a point of tolerable discomfort is felt; subject will hold this position for 30 seconds. Stretch will be repeated 10 times, each day, for six weeks. Reassessment will be done at six weeks and 10 weeks.

Overall Study Other

3

Baseline Characteristics

Foot and Ankle Range of Motion (Stretching) Apparatus

Baseline characteristics by cohort

Measure	Standard of Care or Ankle Exerciser n=26 Participants Patient ankle range of motion will be assessed at clinic visit. They will either receive standard care physiotherapy, or use the ankle exerciser in the following manner: Subjects will train using only one combination of movement, dorsiflexion with inversion. This is done by manipulating the ring so that the medial and anterior ropes are taut. Subject will start with 3 minute warm-up. Subject will then manipulate the ring so that the foot moves into dorsiflexion with inversion until a point of tolerable discomfort is felt; subject will hold this position for 30 seconds. Stretch will be repeated 10 times, each day, for six weeks. Reassessment will be done at six weeks and 10 weeks.Patient ankle range of motion will be assessed at clinic visit. No stretching exercises with the device, but will be provided standard care through physiotherapist in acute cases, and no stretching exercises for chronic patients. Reassessment will be done at six weeks and 10 weeks.
Age, Customized 18 years or older	26 Participants n=5 Participants
Sex/Gender, Customized Male and Female	26 Participants n=5 Participants

PRIMARY outcome

Timeframe: Ten weeks

Population: No participant data or results are available as the investigator left the institution without making them or any analysis available.

Participants randomized into ARM stretching device group will experience less ankle stiffness and an increased range of motion after using the stretching device, as compared to the control group receiving traditional physiotherapy.

Outcome measures

Outcome data not reported

Adverse Events

Standard of Care or Ankle Exerciser

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

Dr. Saul G Trevino

University of Missouri

Phone: 573/884-8840

Email: trevinos@health.missouri.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place